Euref Tomo Protocol Version 015

Protocol
for the Quality Control of the

Physical and Technical Aspects of
Digital Breast Tomosynthesis Systems
Draft version 0.15

January 2014
European Reference Organisation for Quality Assured Breast

Screening and Diagnostic Services
Authors:
R. van Engen, Nijmegen, the Netherlands (Corresponding author)*
H. Bosmans, Leuven, Belgium*
R. Bouwman, Nijmegen, the Netherlands
D. Dance, Guildford, United Kingdom
P. Heid, Marseille, France*
B. Lazzari, Pistoia, Italy*
N. Marshall, Leuven, Belgium
S. Schopphoven, Marburg, Germany*
C. Strudley, Guildford, United Kingdom
M. Thijssen, Arnhem, the Netherlands*
K. Young, Guildford, United Kingdom*
* Members of Physico-technical Steering Group
Contributors:
Alistair McKenzie, Guildford, UK
Jenny Oduko, Guildford, UK
Valentina Ravaglia, Lucca, Italy
Wouter Veldkamp, Leiden/Nijmegen, the Netherlands
…
Corresponding author:
R. van Engen
R.vanEngen@lrcb.nl
National Expert and Training Centre for
Breast Cancer Screening
Radboud University Nijmegen Medical Centre
P.O. Box 6873
6503 GJ Nijmegen
The Netherlands
Collaborating institutes:
Contents
Introduction ................................................................................................................................................................. 5
Philosophy .................................................................................................................................................................... 9
1 X-ray generation .............................................................................................................................................. 12

1.1 Focal spot size (optional) ............................................................................................................................. 12
1.2 Focal spot motion (optional) ........................................................................................................................ 12
1.3 Alignment between X-ray field and reconstructed tomosynthesis image at chest wall edge of the bucky .... 13
1.4 Tube output ................................................................................................................................................... 14
1.5 Tube voltage and beam quality ..................................................................................................................... 15
1.5.1 Tube voltage ........................................................................................................................................ 15
1.5.2 Half Value Layer (HVL) ..................................................................................................................... 15
1.6 Exposure distribution per projection image (optional) ................................................................................ 16
2 AEC-system ...................................................................................................................................................... 17
2.1 Back-up timer/security cut-off ...................................................................................................................... 17
2.2 Short term reproducibility ............................................................................................................................ 17
2.3 Long term reproducibility ............................................................................................................................. 18
2.4 AEC performance ......................................................................................................................................... 18
2.5 Exposure duration per projection and total scan duration ........................................................................... 21
3 Compression..................................................................................................................................................... 22
3.1 Compression force ........................................................................................................................................ 22
4 Image receptor ................................................................................................................................................. 23

4.1 Image receptor response ............................................................................................................................... 23
4.1.1 Response function ............................................................................................................................... 23
4.1.2 Noise analysis...................................................................................................................................... 23
4.2 Detector element failure ............................................................................................................................... 25
4.3 Uncorrected defective detector elements ...................................................................................................... 25
4.4 System projection MTF (optional) ................................................................................................................ 25
5 Image quality of the reconstructed image ..................................................................................................... 27

5.1 Stability of image quality in the x-y plane .................................................................................................... 27
5.2 Z-resolution .................................................................................................................................................. 28
5.3 MTF in the x-y plane (optional) ................................................................................................................... 31
5.4 Noise Power Spectra (optional) .................................................................................................................... 33
Protocol for the Quality Control of the Physical and Technical Aspects of Digital Breast
Tomosynthesis systems, draft version 0.15
5.5 Missed tissue ................................................................................................................................................. 33
5.5.1 Missed tissue at chest wall side in the reconstructed tomosynthesis image.............................................. 33
5.5.2 Missed tissue at the top and bottom of the reconstructed tomosynthesis image ....................................... 33
5.6 Homogeneity of the reconstructed tomosynthesis image .............................................................................. 34
5.7 Geometric distortion ..................................................................................................................................... 34
6 Dosimetry for digital breast tomosynthesis ................................................................................................... 37

6.1 Introduction to DBT dosimetry ..................................................................................................................... 37
6.1.1 Full field geometry .............................................................................................................................. 37
6.1.2 Scanning geometry .............................................................................................................................. 38
6.2 Assessing Average Glandular Dose .............................................................................................................. 39
6.2.1 Assessing AGD using the standard breast model simulated with PMMA .......................................... 39
6.2.2 Assessing clinical breast doses ............................................................................................................ 42
7 Image presentation .......................................................................................................................................... 44

7.1 Monitors........................................................................................................................................................ 44
7.1.1 Ambient light ...................................................................................................................................... 44
7.1.2 Geometrical distortion (CRT displays) ............................................................................................... 44
7.1.3 Contrast visibility ................................................................................................................................ 45
7.1.4 Resolution ........................................................................................................................................... 47
7.1.5 Display artefacts .................................................................................................................................. 47
7.1.6 Luminance range ................................................................................................................................. 48
7.1.7 Greyscale Display Function ................................................................................................................ 48
7.1.8 Luminance uniformity ......................................................................................................................... 49
References .................................................................................................................................................................. 54
Appendix I. Tables for dosimetry calculation in digital breast tomosynthesis ............................................. 56
Appendix II Noise Power Spectrum (NPS) ...................................................................................................... 65

Appendix II.1 NPS in the x-y plane ........................................................................................................................ 65
Appendix II.2 NPS in the reconstructed tomosynthesis image ............................................................................... 65
Appendix IV Specifications and tolerances of equipment and phantoms ............................................................ 67
Appendix V List of definitions (provisional) review by group. Nick ............................................................. 68
Introduction
The fourth edition of the European Guidelines for breast cancer screening and diagnosis, and its
supplement, have been used as a starting point for the development of this protocol. This
protocol is work-in-progress and should be regarded as a preliminary protocol for quality control
in Digital Breast Tomosynthesis (DBT).
Scope:
This protocol applies only to tomosynthesis systems which measure X-ray transmission through
the breast over a limited range of angles, followed by reconstruction of a series of images of the
breast reconstructed for different heights above the detector. These images represent breast tissue
of the corresponding focal planes as well as a remaining portion of overlying tissue. In this
protocol such systems will be referred to as digital breast tomosynthesis (DBT) systems. This
imaging modality is distinct from computed tomography (CT) in which a three dimensional
image is reconstructed using X-ray transmission data from a larger rotation around the imaged
volume. This protocol does not apply to CT or any other mammographic modalities such as
conventional 2D imaging, stereotactic imaging using pairs of images, or any other form of
reconstructive tomography.
X-ray tube
at 0°
X-ray tube X-ray tube
at -φ° at +φ°
Centre of
rotation φ
θ
Breast
Breast
Image
support
receptor
Figure 1 Typical geometry used for a breast tomosynthesis system with a full field detector, showing three
positions of the X-ray tube, the tube rotation angle φ and the projection angle θ for the rotated
position (not to scale).
Two types of DBT geometries are currently available or under development:

1. Full-field geometry: DBT systems incorporating a detector as used in conventional 2D full
field digital mammography (FFDM), and an X-ray tube that rotates above this detector. A series
of individual projection images, in which the whole breast is irradiated in each exposure, are
acquired over a range of angles, as shown in Figure 1.
5
2. Scanning geometry: DBT systems utilising a narrow collimated X-ray beam which scans
across the breast as the X-ray tube rotates, and by which the breast is only partially irradiated at
each position of the X-ray tube, as shown in Figure 2. Due to the design of the system and
continuous readout from the detector, individual projection images might not exist.
X-ray tube
X-ray tube at 0° X-ray tube
at -φ° at +φ°
φ
Breast
Breast
Image
support
receptor
Centre of
rotation
Figure 2 Geometry of a scanning breast tomosynthesis system with a narrow X-ray beam (currently under
development) showing three positions of the X-ray tube (not to scale). In this system both the X-
ray tube and image receptor rotate. The X-ray field is collimated to the image receptor. The limits
of the X-ray field and the ray passing through the centre of rotation are shown.
In Table 1 specifications and geometry of currently available or prototype DBT systems can be
found. These geometries have been taken into account for the calculation of the dosimetry
factors (T-factors) in appendix I.
In FFDM the signal from the detector forms a ‘original data’ image, to which corrections are
applied, including a flat-field correction for ‘bad’ (or defective) pixels and for non-uniformities
of the radiation field, corrections for the offset and gain of detector elements, geometrical
distortion and for time variation during a scan. This corrected image is referred to as the ‘for
processing’ or unprocessed image. The unprocessed image then has processing applied to adjust
the appearance of clinical images, resulting in the ‘for presentation’ or processed image.
In DBT the signal of the individual DBT projection images from the detector are corrected for
bad pixels and non-uniformities of the radiation field, offset and gain of detector elements,
geometrical distortion. Next, on the projection images pre-processing may be applied before they
are reconstructed. After reconstruction, mammography specific post-processing may be applied.
Alternatively, some of the mammography specific processing may be incorporated into the
image reconstruction process.
6
Table 1 Specifications and geometry of breast tomosynthesis systems currently available or in
development (based on Sechopoulos 2013 and subsequent information from manufacturers).
DBT System General Hologic IMS Giotto Philips Planmed Siemens Fujifilm
Electric Selenia TOMO Microdose Clarity3D Mammomat Amulet
Essential Dimensions Inspiration Innovality
Type of geometry Full-field Full-field Full-field Scanning Full field Full-field Full-field
multislit
Energy
Detector type Energy Energy Energy Photon integrating Energy Energy
integrating integrating integrating counting integrating integrating
CsI-a-Si
Detector material CsI-Si a-Se a-Se Si a-Se a-Se
83
Detector element size (µm) 100 70 85 50 85 685
83/166
Focal plane pixel size 100 95-1171 85 50 85 100/150
Continuous,
X-ray tube motion Step-and Continuous Step-and Continuous Sync-and- Continuous Continuous
shoot shoot Shoot
W
Target Mo/Rh W W W W W
Mo: 30µm Al: 700 µm Rh: 50 µm Al: 500 µm Ag: 75 µm Rh: 50 µm Al: 700 µm
Filter Rh: 25 µm Ag: 50 µm Rh: 60 µm
30
Angular range 25 15 402 N/A6 50 15/40
Number of projection 9 15 13 213 15 25 15

images
Source to detector distance 660 700 680 660 650 655 650
(mm)
Distance between detector 40 0 20 4004 4.4 47 46
and centre of rotation (mm)
1
The pixel size in the focal plane changes with height above the breast support table.
2
The projection images may not be equally spaced and may not have the same exposure factor.
3
This system does not have projection images, but 21 datasets from the detector lines.
4
Below the detector.
5
Hexagonal shaped detector elements.
6
Tube movement: 34°.
Aim of this draft version:

DBT systems are currently available on the market and their use is being considered for breast
cancer screening. Guidance on Quality Control (QC) measurements for these systems is
necessary and therefore it has been decided that this draft protocol should be made available. The
tests described can be used to ensure the stability of DBT equipment and to give guidance on
dose measurements. This protocol does not yet cover all aspects of DBT performance testing and
it incorporates some QC tests which are not in their final version. In most cases, limiting values
are not yet given; more experience in DBT and results of clinical trials will be necessary to
determine the limiting technical requirements. In several cases, reference values are given which
have been derived from full field digital mammography (FFDM).
We emphasise that these values should not be used as limiting values, but are solely to be used as
reference values. Another reason for distributing this draft version at an early stage is that
physicists may need specific imaging modes to facilitate adequate testing. A main objective of
this document is to ensure that access to these imaging modes is made available.
This protocol does not give any advice on the suitability of DBT equipment for any
particular clinical task. This has to be determined in clinical trials.
7
Some DBT systems are able to perform both FFDM and DBT imaging, and some DBT systems
are capable of synthesizing a 2D image from the DBT images. The FFDM modality should be
tested according to the current version of the European Guidelines and its Supplement. This
protocol focuses on the DBT modality and does not give guidance on synthesized 2D images.
The test methods described are intended to be applicable to all currently available DBT systems.
However, the differences between the flat-panel DBT systems currently available and in
development, and the scanning slot system in development are such that some QC tests need to
be adopted to be used on the latter. The development of these DBT QC tests started with an
evaluation of whether existing FFDM QC tests could be adapted for use with tomosynthesis.
This approach was appropriate because most current DBT systems are based on existing FFDM
systems. In general, but not necessarily, the same types of detector and X-ray units are used.
Different system design and implementations occur, for example, in the movement of the X-ray
tube and/or the detector, the use of an anti-scatter grid, beam quality and the detector readout
sequences. While radiographic images are ‘processed’ for presentation as FFDM images to
radiologists, they will be ‘reconstructed’ for DBT purposes and may then have further processing
before presentation.
This protocol starts with a philosophy section in which the thoughts behind tests are explained.
Subsequently the different test procedures are described, and terms and definitions can be found
in the definitions section (Appendix III).
8
Philosophy
Digital Breast Tomosynthesis (DBT) is an active area of research. The first clinical systems have
been introduced to the market and systems from other manufacturers are in various stages of
development. Currently available DBT systems have very different characteristics, such as the
angular range for projections, step and shoot versus continuous motion of the tube, new
target/filter combinations, AEC working principles, etc. The clinical task for DBT systems has
not yet been defined: is the purpose of the technology to reduce the obscuring effect of overlying
tissue (small angular range) or is a more CT-like approach with a large angular range and
potentially better suppression of the appearance of overlying tissue more appropriate? Or
perhaps small and large angular ranges will be used for different clinical tasks. Will DBT
systems be used primarily for diagnostic work-up, further assessment of detected abnormalities
or for breast cancer screening? Will DBT be used as a complementary method to FFDM or as a
stand alone screening technique? Answers to these questions will help to determine the limiting
values for the tests proposed in the current document.
In practice, the implementation of DBT QC tests may differ, as some DBT systems can perform
both DBT and FFDM imaging. In this case some of the measurements may need only to be
performed in FFDM mode. When a QC test is performed in FFDM mode it must be verified that
all relevant (exposure) conditions are similar (e.g. target and filter) and the working of the
detector is identical (e.g. binning of detector elements and detector corrections). The
measurement of X-ray beam parameters is a practical challenge when a system is operating in
DBT mode or may require special equipment. Examples of the problems faced are the pulsed
exposure and the changing angle of incidence of the X-ray beam upon the breast support table as
the tube moves. These challenges make measurements in DBT mode of tube voltage, tube output
and HVL impossible with most current kVp and dose measuring equipment.
In developing QC procedures, it is important to consider what images are available for analysis.
For example, on some systems projection images are available, while on other systems they are
not available or do not exist.
This protocol is intended to be used in testing all DBT systems. Limiting values, which may in
the future be set for specific performance parameters, could depend on the diagnostic task for
which an individual system is intended. Because of the differences mentioned above, and the
principle that the same performance parameters should be measured on all systems, most tests
will be performed using the reconstructed tomosynthesis images. The benefit of this approach is
that the image reconstruction is included in the QC test. However, there are some tests of
detector performance that have to be performed using projection or FFDM images, as there is no
valid method of measurement using reconstructed images. For scanning slot systems projection
images are not available, alternative tests or modes need to be investigated for this kind of
systems. Some QC tests, like the evaluation of artefacts caused by the image receptor, may be
performed more easily in FFDM mode (if available) or in projection images.
In FFDM mammography, images with the DICOM tag ‘For processing’ are used for QC
analysis. In these images pixel values are assumed to have a linear relationship to receptor dose
(or can be linearized), and to be shift invariant. The pixel values in reconstructed DBT images
are somehow related to tissue density but a well defined relationship with attenuation does not
exist (like the Hounsfield units in CT imaging). It is not yet known to what extent a DBT system
9
can be assumed to be shift invariant. Furthermore, image reconstruction algorithms can produce
region-specific SDNR and spatial resolution.
Therefore challenges might arise in quantifying image quality using contrast detail analysis or
linear system theory metrics. This is a topic under investigation.
The system should fulfil the requirements regarding breast tomosynthesis systems in the DICOM
standard for DBT systems.
It is noted that for testing purposes e.g. acquisition geometry checks, a special QC mode
incorporating the image reconstruction but excluding additional breast specific image processing
and visualization might be necessary.
Zero degree angle stationary mode: For dose, HVL and tube voltage measurements a stationary
mode at the zero degree angle is required which gives the same exposure as in DBT mode but
without the tomosynthesis movement. All full-field geometry DBT system should have this
mode available. In this mode it must be possible to select the same X-ray spectra as used in DBT
mode. For scanning slot systems a stationary mode may not be not possible, so for these systems
tomosynthesis mode is used instead of zero degree angle stationary mode.
An unprocessed image with all appropriate corrections and flat-fielding in zero degree stationary
mode should be supplied.
Availability of projection images: Some QC tests can only be performed using projection
images. On all DBT systems using a full-field geometry the unprocessed projection images
must be made accessible for QC purposes. On scanning DBT systems projection images may not
exist and therefore cannot be supplied. It is under discussion in which alternative mode
measurements need to be made.
The requirements of DBT systems regarding aspects of image quality are not yet known.
Therefore limiting values are not given in this preliminary QC protocol, but in some cases
reference values are given. An example of such reference values are those given for average
glandular dose for tomosynthesis systems or tomosynthesis mode. The reference values are
identical to the limiting values from the European Guidelines for FFDM. These limiting values
have been chosen as reference values because the benefit of DBT in terms of cancer detection,
versus the cost in terms of radiation dose is not yet clear. Applying too many restrictions at an
early stage in the development of DBT may lead to a suboptimal dose-image quality balance.
However, exceeding the limiting values of 2D mammography should only be accepted if clear
benefit for the patient/client is expected.
10
All relevant exposure information for individual projections should be available from the
DICOM image header, including angular range of movement during projections, angular spacing
between projections, and the distribution of the X-ray exposure between projections.
Manufacturers should also provide the following information: focal spot - detector distance,
focal spot-centre of rotation distance, exposure parameters and exposure time per projection for a
typical beam load, total scan time (with and without initial pre-shot).
The bad pixel map applied to the detector when used in tomosynthesis mode should be made
available to the user.
It is noted that for some systems the first image in the series of projections is the pre-exposure in
zero degree, for other systems the first image is the projection image with largest angle. It should
be investigated which image from the series of projections is the correct image to be used in
stability measurements, i.e. the projection image with largest angle.
11
1 X-ray generation
1.1 Focal spot size (optional)
Method: The method for measuring the focal spot size is described in the 4th edition of the
European Guidelines. Use the projection images, zero degree angle stationary mode image or
FFDM image for evaluation of focal spot size.
Remark: the focal spot size measurement can only be performed in FFDM mode if the same
focal spot is used as in DBT mode.
Limiting values: For reference purposes
Frequency: Optional at acceptance, if image quality problems occur
Equipment: Suitable focal spot size phantom
1.2 Focal spot motion (optional)

For DBT systems in which the focal spot is in motion while the target is emitting x-rays, the
distance that the focal spot travels during the exposure is an important parameter needed when
determining the geometric unsharpness due to focal spot motion for a given object. This test
applies to systems with x-ray tube motion during exposure. In Table 1 the focal spot to centre of
rotation (h) and angular range of the system (θm) are given for currently available DBT systems
and some prototype systems.
Figure 3 Definition of distances for geometric unsharpness motion calculation. The term df is the
dimension of focal spot, the term dm is the extended focal spot size due to motion of the anode
during exposure (for systems with tube motion during exposure). ). The term d1 is the distance
from the focus to the object of interest, the term d2 is the distance from this object to the detector
entrance plane. As an example, geometric unsharpness is shown for an object at some height z o
(+) above the breast support table.
12
Method: Measure the exposure time (tproj) for a typical mAs setting using the zero degree
stationary mode along with the time for a complete scan (tscan). These figures can also be taken
from DICOM header data if accurate and if available.
The focal spot motion length can be calculated using the equation:
t proj (1)
d m  2h m
tscan
Focal spot motion length (dm) should be compared against focal spot size (typically in the region
~0.45 mm at the reference position) to give an idea of the influence of geometric unsharpness
due to focal spot motion.
Remark: As an example of the influence of focal spot motion, the blurring (projected focal spot
travel length (am)) of an object at some point z0 above the breast support table from the extended
focal spot size due to focal spot motion (dm) can be calculated using lengths d1 and d2 as:
d2 (2)
am  d m
d1
Limiting values: For reference purposes

Frequency: At acceptance or software update that changes exposure time for
projections
Equipment: A suitable exposure time meter
1.3 Alignment between X-ray field and reconstructed tomosynthesis image at chest wall
edge of the bucky
Method: Place the X-ray rulers on the bucky, aligned with with the edge of the detector, using
the light field as a guide, see Figure 4. Mark the middle of self developing film and position on
the bucky with this mark aligned with the X-ray ruler. Make an exposure to give sufficient
blackening of the film, without saturating the detector. This may be achieved by making multiple
exposures, or by placing an attenuating material (for example 3mm aluminium) between the self-
developing film and the detector and using a large exposure. Evaluate the coincidence of the X-
ray field and the tomosynthesis image using the markers on the self developing film and the
image of the X-ray rulers in the reconstructed focal plane in which the rulers are in focus, or the
projection images or images acquired in the zero degree angle stationary mode.
13
Bucky
Bucky Light field
Light field
X-ray rulers
X-ray rulers
Self
developing
film
Self developing
film
Figure 4 Set-up for measuring coincidence of reconstructed and irradiated volume on the bucky, top view
and 3D view.
Limiting values: Chest wall side: X-ray field must extend no more than 5 mm beyond the
edge of the image receptor (when using projection images)/reconstructed
tomosynthesis image.
Frequency: At acceptance and every six months

Equipment: X-ray rulers, self developing film
1.4 Tube output

For measuring tube output, a distinction is made between systems that have full-field geometry
and scanning geometry. A description of the different geometries is given in the introduction of
this protocol and in Dance et al 2011.
Method: Measure the tube output at all clinically used spectra. Measure the tube output of the
spectrum used for 45 mm PMMA in the clinically used AEC mode 5 times to check short term
reproducibility.
- For a system with a full field geometry: Position the dose meter within the X-ray field
60 mm from chest-wall side underneath and in contact with the compression paddle and
measure the incident air kerma in the zero degree angle stationary mode. The dose
meter should be positioned on a line extending from the tube focal spot to a point on the
mid-line of the breast support table 60 mm from the chest wall edge. If the dose meter
has back scatter correction the recommended position is directly on the breast support
with the paddle in contact.
- For the scanning geometry: Position the dose meter on the bucky surface centred
laterally and 60 mm from chest-wall side. Measure the incident air-kerma for the
scanning beam.
Note: In zero degree angle stationary mode the measured tube output might differ slightly from
the FFDM mode due to the pulsed exposure.
14
Limiting values: No limiting values, tube output is measured for dosimetry purposes only.
Tube output of 5 consecutive measurements should be within 5% of the
average tube output.
Frequency: Every 6 months
Equipment: Dose meter with suitable calibration.
1.5 Tube voltage and beam quality

The beam quality of the emitted X-ray beam is determined by tube voltage, target material and
filtration. Tube voltage and beam quality are used to calculate average glandular dose.
1.5.1 Tube voltage

Method: The method for measuring the tube voltage is described in the European Guidelines, 4th
edition. Perform the measurements in the zero degree angle stationary mode. The tube voltage
range used clinically may be sampled, perform at least 5 measurements.
Note: In DBT mode the measured tube voltage might differ slightly from the FFDM mode due to
the pulsed exposure in DBT mode.
Limiting values: Accuracy for the range of clinically used tube voltages: < ± 1 kV
Reproducibility: < ± 0.5 kV
Equipment: Suitable tube voltage meter
1.5.2 Half Value Layer (HVL)

The Half Value Layer (HVL) can be calculated by inserting thin aluminium filters into the X-ray
beam and measuring the attenuation. Perform the measurements in the zero degree angle
stationary mode.
Method: Position the dosimeter at the reference position. Place the compression paddle as high
up as possible between focal spot and the bucky. Limit the X-ray field to the area of the
dosimeter. Perform measurements for each clinically used target filter combination. Sample the
tube voltage range such that at least 3 measurements are performed for each clinically used target
filter combination, unless fewer than 3 tube voltages need to be measured. Make an exposure
without an aluminium filter and repeat the exposure twice with different thicknesses of
aluminium filter placed on the compression paddle. The thicknesses of the aluminium filters
should be chosen such that the measured incident air kerma levels are just above and below half
the incident air kerma measured without filter.
Determine the HVL using equation (3):
 2  Y2   2  Y1 
X 1  ln    X 2  ln  
 Y 0   Y0  (3)
HVL 
Y 
ln  2 
 Y1 
In this equation Y0 is the air kerma reading without additional attenuation and Y1 and Y2 are the
air kerma readings with added aluminium filter thicknesses of X1 and X2 respectively.
15
Note: In DBT mode the measured HVL might differ slightly from the FFDM mode due to the
pulsed exposure in DBT mode.
Limiting values: No limiting values, only measured for the calculation of average glandular
dose
Frequency: At acceptance and after replacement of the X-ray tube
Equipment: Suitable dose meter
1.6 Exposure distribution per projection image (optional)

The aim of this test is to determine the incident air kerma (at the surface of a 45 mm PMMA)
delivered per projection. This may be constant for some designs, other DBT systems may vary
the air kerma per projection according to some defined regime.
Method: If the dosimeter has a suitable waveform option, incident air kerma of each individual
projection image can be measured. Position the dosimeter on a line extending from the tube focal
spot to a point on the mid-line of the breast support table 60 mm from the chest wall edge.
Initiate an exposure in zero degree angle mode and measure the incident air kerma for each
projection image. Use clinically relevant exposure parameters for a standard 45 mm thick
PMMA phantom.
Verify whether the distribution of the doses conforms to the description in the DICOM header of
the images or to the description at the console.
Note: Depending on the workings of the AEC, performing the measurement in the zero degree
angle stationary mode might give slightly different results to those obtained with a moving tube.
Alternatively the pixel values in the projection images can be used to determine the exposure
distribution between projection images. Position the standard 45 mm thick PMMA phantom on
the bucky and make an exposure in the clinically used AEC mode. Using the linearized mean
pixel value from the reference ROI in each projection image, calculate the relative dose per
projection image, and compare the relative dose per projection to that indicated by the current-
time product for each projection in the DICOM header.
Limiting values: Manufacturers specification
Frequency: At acceptance
Equipment: Dosimeter with suitable waveform option
16
2 AEC-system
If multiple AEC modes are used clinically, these modes must be measured at acceptance and
after upgrade of the AEC software.
2.1 Back-up timer/security cut-off

Method: Make an exposure in the clinically used AEC mode with a highly attenuating object
covering the AEC part of the image receptor. Record the mAs value at which the exposure is
terminated.
Warning: An incorrect functioning of the back-up timer or security cut-off could damage the
tube. To avoid excessive current–time product (mAs) consult the manual for maximum permitted
exposure time.
Note: The exposure might be terminated after the pre-exposure, for the reason that the image
quality which is aimed for by the AEC cannot be achieved (security cut-off). This prevents
unnecessary exposure to the patient/client. The exposure might also be terminated at a very high
exposure, to prevent damage to the X-ray tube (back-up timer).
Limiting values: The back-up timer and/or security cut-off should function according to
specifications
Frequency: Yearly
Equipment: Suitable high attenuation object e.g. metal plate.
2.2 Short term reproducibility

Method: Position a 45 mm thick homogeneous PMMA phantom on the bucky and initiate an
exposure in the clinically used AEC mode. Record the exposure settings. Repeat this procedure 4
times. Measure the average pixel value and standard deviation in the reference ROI in the first
projection image and calculate linearized SNR. Calculate the variation in current–time product
(mAs) and in SNR.
Limiting values: Variation in total current–time product (mAs) between images < 5%,
variation in SNR between image < 10%.
Frequency: Every six months
Equipment: Homogeneous block of PMMA, 45 mm thick covering the whole image
receptor + 5 mm on all sides
17
2.3 Long term reproducibility
Method: Position the standard 45 mm thick PMMA block on the bucky and initiate an exposure
in the clinically used AEC mode. Record the exposure settings. Measure the average pixel value
and standard deviation in the reference ROI in first projection image and calculate SNR. Average
pixel value, SNR and exposure settings are tracked over time.
Limiting values: The variation in current–time product (mAs), average pixel value and
SNR in the reference ROI should be <10% between images if the
exposure factors remain unchanged.
Frequency: Daily/weekly, after system calibration and after maintenance
Equipment: Standard 45 mm thick PMMA block covering the whole image receptor +
5 mm on all sides
2.4 AEC performance

This test uses readily available QC equipment and more advanced tests are under development.
Method: Compensation for object thickness should be measured by exposures of PMMA plates
in the thickness range from 20 to 70 mm (steps of 10 mm) and the standard 45 mm thick PMMA
block, using the clinically used AEC mode.
200µm Al object
(10 x 10 mm)
200 µm Al object (10 x10 mm)
10 mm
10 mm
60 mm
ROIs (5 x 5 mm)
Figure 5a Setup for the breast thickness and composition measurements (50 mm PMMA + 10 mm air gap),
top view and 3D-view.
18
Compression
paddle
Compression
50 mm PMMA paddle
200 µm Al object
(10 x 10 mm)
50 mm PMMA
200 µm Al object
(10 x 10 mm)
Figure 5b Setup for the breast thickness and composition measurements (50 mm PMMA + 10 mm air gap),
front and side view.
10 mm
Movement of X-ray tube
10 mm
Figure 5c The ROI positions to calculate SDNR.
Image two 10 mm thick stacked PMMA plates covering the whole image receptor, with an
aluminium sheet of dimensions 10x10 mm and 0.2 mm thick wedged between the plates.
Position the aluminium at a distance of 60 mm from chest wall side and centred laterally, as
shown in Figure 5. Image the stack in the clinically relevant AEC mode, if necessary the image
can be made in manual mode with settings as close as possible to the clinical AEC settings for
the equivalent breast thickness.
19
Table 2 Height of the compression paddle when using different PMMA thicknesses.
PMMA thickness Height of the

(mm) compression
paddle
(mm)
20 21
30 32
40 45
45 53
50 60
60 75
70 90
Repeat this measurement for the PMMA thicknesses according to Table 2 column 1 by adding
additional slabs of PMMA on top of the stack. The compression paddle should be positioned as
given in Table 2 column 2. This is achieved by leaving an air gap between the PMMA plates and
the compression paddle.
If compression is necessary to make an exposure, then spacers may be used, but must be
positioned such that they do not reduce transmission of X-rays to the central and chest wall
regions of the image at any tube angle. This may be achieved by placing spacers along the back
edge of the PMMA.
Position a 5 mm x 5 mm ROI in the centre of the image of the aluminium sheet at the focal plane
with the image of the sheet, and two 5mm x 5mm ROIs in the background areas on the chest
wall and nipple sides of the aluminium sheet, see Figure 5c. The centres of both background
areas should be at a distance of 10 mm from the centre of the ROI in the aluminium sheet. If the
focal plane has a significant degree of non-uniformity it may be necessary to compensate for this
by using ROIs subdivided into 1mm x 1mm elements and using the averages of the mean pixel
values and standard deviations from the elements. Measure the pixel values and standard
deviations in the ROIs on the central projection images or zero degree angle stationary mode
images.
Calculate PV(background) and SD(background) according to:
 SD(ROI
2
)
SD(backgro und)  1 n
(4)
2
 PV(ROI
2
)
PV(backgro und) 
n
1 (5)
2
20
Calculate the SDNR of the aluminium object:
PV ( signal )  PV (background )
SDNR  (6)
SD(backgro und)
limiting values: Not yet established, SDNR values are calculated for reference purposes, to
ensure stability
Equipment: Aluminium sheet, seven PMMA slabs of 10 mm thickness, one PMMA
slab of 5 mm thickness
2.5 Exposure duration per projection and total scan duration

Exposure time per projection and total scan time are important parameters of system
performance (see focal spot motion tests). The long scan times may lead to motion unsharpness
and/or artefacts.
Method: Position the standard 45 mm thick PMMA block on the bucky and make an exposure in
the clinically used AEC mode. Measure the time of each projection image and the time between
the start of the first and the end of the last exposure. If the exposure time meter interferes with
the exposure chosen by the AEC, the standard 45 mm thick PMMA block should be imaged
without the exposure time meter The exposure factors should be recorded and simulated
afterwards in manual mode with the exposure time meter in the X-ray beam.
Limiting values: No limiting values set, clinical evaluations are required to evaluate
potential motion artefacts. Measured values can be used to ensure stability
and similar settings on the same type of system.
Frequency: Exposure time: acceptance test, every six months, Total scan time: at
acceptance and if changes have been made in the acquisition of images.
Equipment: Exposure time meter with a waveform option
21
3 Compression
3.1 Compression force
Method: Measure the motorised compression force with a compression force test device (use
compressible material e.g. a tennis ball to protect the bucky and compression device). Attention
should be given to the applied compression and the accuracy of the indication. Examine the
compression paddle visually for cracks and sharp edges.
Record the maximum compression force and the compression force after 1 minute of
compression. Report any visual damage of the compression device.
Limiting values: Maximum motorized compression force may not exceed 200 N and must
be at least 150 N. The decline in compression force within 1 minute may
not exceed 10 N. No sharp edges and cracks in the compression paddle
should be present.
Frequency: Yearly
Equipment: Compression force test device
22
4 Image receptor
4.1 Image receptor response
4.1.1 Response function

Response function is measured in DBT projection images or in images acquired in zero degree
angle stationary mode.
Method: Remove the compression paddle and any other removable parts from the X-ray beam.
Position a 2 mm thick aluminium plate as close as possible to the X-ray tube.
Set the target/filter combination and tube voltage which is chosen in fully automatic mode for the
standard 45 mm thick PMMA block. In manual mode, set the minimum mAs value. Image the
aluminium plate. Increase the mAs-value and repeat the image. Acquire several scans (typically
8 scans) at different mAs-values over the available range, increasing the current-time product
(mAs) by a factor of approximately 1.4 (if possible) between exposures.
It is optional to repeat the measurement for all target-filter combinations, with a clinically
relevant tube voltage for each combination.
It is optional to measure or calculate, from tube output measurements, the incident air kerma on
the detector surface to use instead of current–time product (mAs) in this evaluation.
Measure the mean pixel value and standard deviation in the standard ROI on the first image of
the zero degree angle stationary mode or the first projection image to limit the influence of lag
and ghosting in the measurements. Plot mean pixel value against mAs (or incident air kerma at
the detector) and check whether the response function is according to manufacturer’s
specification.
Remark: Detector gain (the gradient term of the response function) is usually increased for DBT
mode compared to standard 2D mammography mode, because of the lower exposure per
projection used in DBT systems.
Limiting values: Results at acceptance are used as reference.
Equipment: 2 mm thick aluminium plate (99% purity), optional: suitable dose meter.
4.1.2 Noise analysis

Noise analysis is performed in DBT projection images or images acquired in zero degree angle
stationary mode.
The aim of this test is to quantify the contribution of different noise components to the total
image noise in order to provide additional information on the performance of the imaging
system. This may assist in trouble-shooting if image quality problems occur.
General requirement: For systems with a non-linear response, the pixel data must be linearized
before analysis.
23
Noise in images can be subdivided in electronic noise, quantum noise and structural noise:
SD2=ke2 + kq2 *p + ks2 * p2 (7)
SD = standard deviation in reference ROI
ke = electronic noise coefficient
kq = quantum noise coefficient
ks = structural noise coefficient
p = average pixel value in reference ROI
Electronic noise is assumed to be independent of the exposure level and arises from a number of
sources: dark noise, readout noise, amplifier noise.
Structural noise is present due to spatially fixed variations of the gain of an imaging system. The
flatfielding performed in DR systems will largely remove the effects of structural noise. Due to
the limited number of images used for the flatfield mask and the associated noise in the mask,
some structural noise will be present. Furthermore flatfielding might not be performed for
projection images individually, leading to some additional structural noise.
Quantum noise arises due to the variations in X-ray flux.
Method: The images acquired for measurement of detector response (section 4.1.1) are used for
this test.
It is optional to repeat the measurement for all target-filter combinations, with a clinically
relevant tube voltage for each combination.
Measure or calculate the incident air kerma on the detector surface from tube output
measurements for all spectra to be able to plot against detector air kerma instead of pixel value.
Analysing steps:
1. Measure pixel value and SD in the reference ROI.
2. Linearize the response function from paragraph 4.1.1 if the response is non-linear.
3. Plot SD² against pixel value (or detector incident air kerma).
4. Fit a curve to the points using equation (7) and determine the noise coefficients
The calculated noise coefficients can be used to plot the percentage of the total relative noise for
all noise components against pixel value (~detector incident air kerma).
Note: Quantum noise may not be the largest noise component in individual projection images.
Limiting values: Use the noise coefficients for reference purposes to ensure stability and
similar settings/quality on the same model of system.
Equipment: 2 mm thick aluminium plate, optional: dose meter
24
4.2 Detector element failure
Method: Obtain the most recent “bad pixel map” for tomosynthesis mode from the system.
Remark: this map might differ from the bad pixel map in FFDM mode due to the differences in
readout of the detector or pixel binning after readout.
Limiting value: At present no limits have been established. It is suggested that the
manufacturer’s limits are used.
Equipment: None
4.3 Uncorrected defective detector elements

The uncorrected defective detector elements test is performed on images acquired in
tomosynthesis mode: projection images or zero degree angle stationary mode images.
Method: Make five images of the standard 45 mm thick PMMA block and determine whether
any pixel deviates more than 20% in value compared to the average value in an ROI of 5 mm x 5
mm. For projection images the pixel value of uncorrected defective detector elements should
deviate in all images.
Limiting value: No uncorrected defective detector elements should be visible and any
pixel in an ROI of 5mm x 5mm should deviate less than 20% in value
compared to the average value in this ROI.
Equipment: Standard 45 mm thick PMMA block
4.4 System projection MTF (optional)

The MTF test is performed using DBT projection images.
The system MTF measured in the projection images includes the following sources of blurring:
focal spot size, focal spot motion and detector MTF (x-ray converter MTF and pixel sinc MTF)
and detector binning. The system MTF measured in zero degree angle stationary mode includes
the same blurring sources with the exception of focal spot motion.
The MTF in the tube travel direction may be strongly influenced by the effective size of the focal
spot due to tube motion, which in turn depends on the exposure pulse length per projection
image. Blurring (for some object) in the projection images due to focal spot size and focal spot
motion depends on the position of the rotation point and the position in the z-direction (distance
above the compression paddle) of the object. Hence, a system MTF in the projection images
should be measured at a number of positions above the bucky. Blurring or resolution loss in the
detector itself can be isolated by measuring MTF in FFDM or zero degree angle stationary mode
with edge on the detector housing.
Method: Remove the compression paddle. Position a aluminium plate (1 or 2 mm thick) as close
as possible to the X-ray tube. Place the MTF edge on the bucky at a small angle (~ 3O) to the
orientation of the pixel matrix, with the centre of the edge to be used on the midline at a distance
25
of approximately 60 mm from the chest wall edge. Perform a DBT scan using the same beam
quality as would be selected by the AEC for 45mm PMMA. Ideally one would increase the
current–time product (mAs) to three times the AEC value to reduce the effect of noise on the
measurement, but it is likely that the exposure duration for each pulse would be increased which
should be avoided , unless the system can increase the tube current and keep the exposure times
constant.
A check should therefore be made to ensure that the pulse exposure time is a typical clinical
value. Rotate the MTF edge through 90o and repeat to obtain the MTF in the orthogonal
direction. (Alternatively the MTF can be measured in both directions in a single image using a
suitable MTF test tool with two suitable orthogonal edges.) Repeat the pairs of orthogonal
images at 40 mm and 70 mm above the table surface. To achieve this the MTF tool should be
placed on low contrast supports (e.g. expanded polystyrene blocks positioned such that they do
not influence the area used for MTF analysis) For routine measurements the MTF only needs to
be assessed at 40 mm height above the table surface. Calculate the MTF for each image using
appropriate software (e.g. OBJ_IQ_reduced as described in NHSBSP Equipment Report 0902).
Re-bin the MTF data at 0.25mm-1 spatial frequency intervals. Find the spatial frequency for MTF
values of 50% and 10%.
Options: collimate field to 100 x 100 mm if appropriate. Reposition the edge between DBT scans
such that the horizontal edge and vertical edge are at the same position on the detector.
Remark: Some systems use some kind of pixel binning of the projection images. The binning
used by the system should be noted as it is obviously an important source of blurring. Note that
some systems may save the projections binned or un-binned; it is possible that systems save un-
binned projection images and bin these images before reconstruction.
Remark: If the temporal response of the x-ray detector (e.g. in terms of x-ray fluorescence or
charge trapping and release in a photoconductor) is not sufficiently fast with respect to the
projection image acquisition rate then signal carry over (lag) between projections will be seen.
The cumulative effect of the lag is changing brightness near the region of the edge. This results
in a ramp function superimposed on the high value part of the edge spread function and
ultimately leads to a reduction in MTF at low spatial frequencies.
Limiting values: Record spatial frequency for 50% and 10% points for the MTF; this value
should be within 10% of previous test and baseline.
Frequency: At acceptance: at the bucky surface and at 40 and 70 mm above the bucky
tab le. Every six months:at 40 mm height above the bucky table.
Equipment: 1 mm thick steel sheet of dimension 50 x 50 mm² (min.) with machined
straight edges. Appropriate MTF calculation software, 2 mm thick
aluminium plate.
26
5 Image quality of the reconstructed image
5.1 Stability of image quality in the x-y plane
The use of model observers is currently being investigated for image quality evaluation in breast
tomosynthesis systems. Future versions of this protocol might include tests using model
observers For now, it is advised to use the methods and phantoms as used in FFDM, such as the
CDMAM and TORMAM phantoms. It is realized that the tests proposed in this section have
been designed for FFDM and have problems/disadvantages when used on tomosynthesis
systems.
With the current methods and phantoms it is not possible to quantify image quality in the
reconstructed tomosynthesis images. However it is important to investigate in-plane and inter-
plane image quality, even though the method of testing does have limitations. This will quantify
some aspects of the reconstructed images but more importantly will enable testing the stability of
equipment and will enable comparisons of performance for systems of the same brand and
model.
It is emphasized that comparisons between different models cannot be made using this
approach.
A test object which is used for this purpose should be able to test some measure of resolution and
SNR. Examples of such a test object are the CDMAM phantom and the Tormam phantom.
5.1.1 CDMAM phantom

The limitations of the CDMAM phantom are that the objects within the phantom are cylindrical,
with the long axis perpendicular to the detector. As a consequence the effective thickness varies
with the angle of incidence of the X-ray beam. Furthermore the relationship between CDMAM
scores on homogeneous backgrounds and the image quality (detection of tumours) of clinical
reconstructed tomosynthesis (with structured backgrounds) image quality is not known yet and
might be complex due to optimization by the reconstruction algorithm.
Method: Image the CDMAM phantom in the middle of a 40 mm stack of PMMA using exposure
factors as would be selected automatically for a 60 mm equivalent breast. Repeat to obtain a total
of 8 images, moving the phantom slightly between exposures. Score the reconstructed
tomosynthesis images of the CDMAM phantom using human observers and calculate the CD-
curve according to the supplement to the fourth edition of the European Guidelines.
For some DBT systems it is possible to score the focal plane where the image of the CDMAM
phantom is in focus using CDCOM, in which case 16 CDMAM images may be used. It is
advisable to ensure that the entire CDMAM is brought into focus in a single focal plane by
careful positioning of the phantom to compensate for any tilt of the reconstructed focal planes
relative to the breast support table. As CDCOM is designed to read images in the FFDM format,
it is necessary to extract the focal plane where the CDMAM is in focus from the reconstructed
tomosynthesis image. Where there is significant low frequency non-uniformity in the
reconstructed focal planes, flatfielding should be applied before automated reading using
CDCOM. A suitable flatfielding algorithm involves cropping to the useful area of the CDMAM
27
and padding out to achieve an image size equal to the nearest power of two. A Butterworth filter
is applied in the frequency domain to remove the higher frequencies including the grid and
contrast details of the CDMAM, using a fourth order filter with a cut-off of 5mm. The original
image is then divided by the original image and the pixel values rescaled.
Note that the use of CDCOM for reading tomosynthesis images has not been validated by
comparison with human reading and converting the results of this automated analysis to
predicted human values using the method described in the Supplement to the European
Guidelines may not be correct. However, automated reading and analysis of tomosynthesis
CDMAM images using software designed for 2D images may be a useful interim tool for
monitoring the stability of DBT image quality.
Limiting values: The measured contrast threshold values can be used for reference purposes
to ensure stability and similar settings/quality of the same type of system.
Note: The limiting values for FFDM image quality measurements cannot
be applied to DBT.
Frequency: Every 6 months.
Equipment: CDMAM phantom, PMMA plates
5.1.2 TORMAM phantom

The TOR MAM phantom, like the CDMAM, has limitations due to having been designed for
testing the image quality of 2D images. However it may be used as an alternative interim tool for
monitoring the stability of image quality in reconstructed tomosynthesis focal planes.
Method: Image the TORMAM phantom on top of a 30 mm stack of PMMA using automatically
selected exposure factors. Carry out a visual assessment of the image of the TORMAM in the
focal plane where it appears in focus. For this assessment it is necessary to use a primary display
monitor under appropriate conditions, with window level and width and zoom functions adjusted
to maximise visibility of the details. A scoring system may be used, where points are
accumulated for discs, filaments and specks according to how clearly they are visualised.
However such systems are highly subjective and likely to vary significantly between observers
and between observations by the same observer on different occasions. Alternatively assessment
may be made by comparison to a baseline image, recording whether the visibility of details in the
image are the same, or better or worse than in the baseline image. When comparing against a
baseline image the two images should be displayed simultaneously.
Limiting values: The visibility of details in a baseline image can be used for reference
purposes to ensure stability and similar settings/quality of the same type of
system. Note: Standards for the visibility of details in a 2D TORMAM
image cannot be applied to DBT.
Frequency: Every 6 months.
Equipment: TORMAM phantom, PMMA plates
5.2 Z-resolution
Tomosynthesis imaging of a 3D phantom containing 1 mm diameter aluminium spheres enables
an assessment to be made of the inter-plane spread of the reconstruction artefacts associated with
each sphere, which appear in focal planes adjacent to the plane representing the actual height of
the sphere. A measurement of the spread between focal planes of the reconstruction artefacts
associated with a sphere can be regarded as a measure of inter-plane resolution or z-resolution.
28
This measurement is dependent upon the size of the sphere. There is a change in the appearance
of reconstruction artefacts between focal planes; typically the sphere stretches into a faint line in
the direction of tube motion. There is often also a shift in the position of the artefact within the
focal plane, relative to the position of the sphere in focus, due to magnification effects.
Therefore, when assessing inter-plane spread, it is not sufficient to include only those pixels in a
vertical line through the position of the sphere in the reconstructed volume. Instead the vertical
component of inter-plane spread is assessed, by plotting a profile through the maximum pixel
value in the vicinity of the sphere from each of the adjacent focal planes.
A test phantom is used which contains several 1mm aluminium balls in order to make
simultaneous measurements at multiple positions across the field of view within a single image.
Images acquired using the geometric test phantom (section 5.7) may be used for this purpose,
enabling the two tests to be combined.
10 mm PMMA
5 mm PMMA
incl. Al spheres
50 mm PMMA
Al spheres (1 mm diameter)
embedded in 5 mm PMMA
Figure 6b Setup for the evaluation of z-resolution (60mm PMMA + 5mm phantom), top view and 3D-view.
29
Compression
paddle
10 mm PMMA
Compression
paddle
5 mm PMMA
incl. Al spheres
10 mm PMMA
40 mm PMMA 5 mm PMMA
incl. Al spheres
40 mm PMMA
Figure 6c Setup for the evaluation of z-resolution (50mm PMMA + 5mm phantom), front and side view.
Method: Position six 10 mm thick slabs of PMMA on the bucky. Position the 5 mm thick
phantom containing the aluminium spheres between the first and second slab and make an
exposure. Repeat with the aluminium spheres between the third and fourth slab and again
between the fifth and sixth slab.
A visual inspection is made of the appearance of artefacts and how they change and shift
between focal planes.
Quantitative measurements are made of the vertical component of the artefact spread in terms of
full width at half maximum (FWHM) measurements in the direction perpendicular to the
detector surface. The half maximum value is taken to be the midpoint between the highest pixel
value within the reconstructed image of the ball and the average background pixel value taken
from an artefact free region surrounding the ball in the plane in which the ball is in focus.
The vertical spread of the artefact is not necessarily measured in a straight line through the
reconstructed image: the maximum pixel value within the artefact for each plane perpendicular
to the direction of the FWHM is used, thus enabling allowance to be made for angulation and
inhomogeneous spread of the artefact. Automated software or DICOM viewer tools are used to
produce composite images of pixel maxima and reduce them to single lines of maxima, from
which the vertical FWHM is calculated either by linear interpolation or fitting a polynomial
spline to the data. Where the shape of the vertical profile is complex it may not be sufficient to
measure the FWHM: for example, if the base of the profile is particularly broad then it may be
desirable to quantify this by also measuring the full width quarter maximum.
This analysis is most easily carried out by using dedicated software, which will be made
available on the EUREF website.
30
Limiting values: To be determined, the FWHM values can be used for reference purposes
and to ensure stability and similar settings/quality of the same model of
system.
Equipment: 5 mm thick phantom containing aluminium spheres (1 mm diameter), six
10 mm thick PMMA slabs
5.3 MTF in the x-y plane (optional)

The use of linear system theory metrics on reconstructed images is under debate. Especially for
iterative reconstruction techniques, it is not known whether linear system theory metrics are
valid. The relationship between these metrics and image quality of clinical reconstructed
tomosynthesis (with structured backgrounds) is not known yet and might be complex due to
optimization within the reconstruction algorithm. Currently the measurement of MTF could be
performed to monitor stability of the tomosynthesis system and to allow comparison of results
obtained from systems of the same model.
The system MTF measured in the reconstructed planes (effectively the total system MTF for the
focal plane in which the wire is located) includes all the sources of blurring in the system:
detector MTF, and all additional sources of unsharpness and the reconstruction algorithm. DBT
is a pseudo-3D technique and should ideally be measured using a method that gives the 3D MTF.
The method given below does not give the 3D MTF but instead the in-plane MTF (x-y) in tube
travel and chest wall-nipple directions.
5 mm PMMA
Tungsten wire
10 mm PMMA
φ ~ 3° (
Tungsten wire
60 mm
30 mm spacer
Figure 7a Setup for the evaluation of MTF in focal plane, top view and 3D-view.
31
5 mm PMMA
Tungsten wire
5 mm PMMA
10 mm PMMA Tungsten wire

30 mm spacer
10 mm PMMA
30 mm spacer
Figure 7b: Setup for the evaluation of MTF in focal plane, front and side view.
Method: In-plane MTF is measured using a 25 µm diameter wire held within two PMMA plates
of 5mm and 10mm thick, see Figure 7. The wire is stretched across a 10 mm thick, 240 x 300
mm PMMA plate. A 5 mm thick plate is then placed on top of this. The wire should be stretched
(held under tension) so it is straight. Remove compression paddle. Position the MTF phantom
(15 mm PMMA containing the wire) such that it is held 40 mm above the breast support
platform. To measure the MTF in the chest wall-nipple direction, position the wire to run left-
right across the detector at 60 mm from the chest wall edge. To measure the MTF in the tube-
travel direction rotate the MTF phantom 90°, so the wire is centred left-right and is orthogonal to
the tube-travel direction (at an angle). It is vital that the wire is held parallel to the detector and
therefore remains within a given reconstructed plane. This can be difficult to achieve. Take care
that the phantom is not vibrating or moving as this will degrade the MTF. Set standard beam
quality (typical target, filter, tube voltage and current–time product (mAs) for 45 mm PMMA)
but no added filtration. Acquire a DBT scan and reconstruct using the reconstruction algorithm
of interest (typical clinically used algorithm). Calculate in-plane MTF (left-right and front back)
from the in-focus plane containing the wire using appropriate software. There may be some
overshoot in the MTF, depending on the reconstruction algorithm used. Whereas for MTF
measurements of projection images the MTF is normalized to MTF[0], for DBT it should be
normalized to max(MTF). Re-bin to 0.25 mm-1 spatial frequency bins. Record spatial frequency
for 50% and 10% points for the MTF.
Remark: system linearity and stationarity of statistics is assumed. The use of a small signal (thin
wire) helps to fulfil this assumption, however this will not be fulfilled for non-linear
reconstruction algorithms such as iterative methods. The usefulness of linear system theory
metrics in DBT QC should be investigated further.
Remark: The contrast in the image of the MTF phantom should not be too high. Artefacts might
be introduced which might influence the measurement.
32
Limiting values: Record spatial frequency for 50% and 10% points for the MTF. These
values can be used for reference purposes and to ensure stability and
similar settings/quality of the same type of system.
Equipment: 25 µm diameter W wire. Appropriate MTF calculation software.
5.4 Noise Power Spectra (optional)

See Appendix II.
5.5 Missed tissue

Missed tissue at chest wall side and at the top and bottom of the reconstructed tomosynthesis
image is evaluated.
5.5.1 Missed tissue at chest wall side in the reconstructed tomosynthesis image
Method: Position two X-ray rulers on the bucky perpendicular to and aligned with the chest wall
edge and acquire an image.
Evaluate the amount of missed tissue beyond the chest wall edge of the reconstructed plane
corresponding to the surface of the bucky.
Instead of X-ray rulers, a phantom with markers can also be used.
Limiting values: Width of missed tissue at chest wall side ≤ 5 mm.
Equipment: X-ray rulers
5.5.2 Missed tissue at the top and bottom of the reconstructed tomosynthesis image
Method: Position some small high contrast objects (e.g. staples, paperclips) at the centre, near
the chest wall edge and in each corner, on the bucky surface, and afterwards taped to the
underside of the compression paddle..Place some attenuating material between the bucky and
compression paddle (for example 3mm sheet of aluminium) and acquire a tomosynthesis image
under AEC control. Check that all objects are brought into focus in focal planes near to the
bottom and top of the reconstructed image, respectively..
Limiting values: All the objects at the bottom and top of the stack should be brought into
focus within the reconstructed tomosynthesis image.
Equipment: Small high contrast objects
33
5.6 Homogeneity of the reconstructed tomosynthesis image
The evaluation of homogeneity is performed on the reconstructed tomosynthesis image.
Method: Position a 45 mm thick PMMA block on the bucky covering the whole field of view
and make an exposure in the clinically used AEC mode. Record the exposure factors. The
reconstructed tomosynthesis planes should be divided in regions-of-interest (ROIs) of 5.0 mm by
5.0 mm and averaged with adjacent focal planes covering a vertical range of 5mm . In each ROI
the average pixel value, standard deviation and variance should be calculated. Signal-to-noise
ratio (SNR) is calculated for each ROI by dividing the average pixel value by the standard
deviation.
For the calculation of homogeneity and stability a program, Homogenei3D has been developed,
which will be made available via the Euref website (www.euref.org).
Detector artefacts might be easier to evaluate on zero degree angle stationary mode or projection
images. The method for evaluation of projection images is similar to FFDM.
Limiting values: No disturbing artefacts should be present.
Frequency: Daily/Weekly
Equipment: 45 mm thick PMMA block covering the whole field of view
5.7 Geometric distortion

Images of a phantom containing a rectangular array of 1mm diameter aluminium spheres may be
used to assess geometric distortion, see Figure 8.
Figure 8a Phantom for evaluation of geometric distortion; The phantom consists of a 5 mm thick PMMA
slab with a rectangular array of 1mm diameter aluminium spheres embedded in the middle of the
slab. The balls are spaced at 55mm interval with an accuracy of +/-0.1mm.
Method: The geometric distortion phantom is imaged at the bottom, middle and top of a 60 mm
stack of PMMA.
34
5 mm PMMA
incl. Al spheres
60 mm PMMA
Al spheres (1 mm diameter)
embedded in 5 mm PMMA
Figure 8b Setup for the evaluation of geometric distortion (60mm PMMA + 5mm phantom on top), top view
and 3D-view.
Compression
paddle
5 mm PMMA
Compression
incl. Al spheres
paddle
5 mm PMMA
60 mm PMMA incl. Al spheres
60 mm PMMA
Figure 8c Setup for the evaluation of geometric distortion (60mm PMMA + 5mm phantom on top), front
and side view.
Analysis software can be used to find the position of each sphere in the x, y and z directions.
This software will be made available via the EUREF website. This information can be used to
assess whether the focal planes are flat (ie no distortion in the z direction), whether they are tilted
relative to the plane of the surface of the table, and to assess whether there is any distortion or
inaccuracy of scaling within the focal planes.
35
Note: If it is found that the reconstructed focal planes are tilted relative to the surface of the
breast support table, this information can be useful in determining how to position e.g. a
CDMAM such that the whole phantom is brought into focus within a single focal plane (section
5.1).
Limiting values: Any distortion or scaling error should be within the manufacturer’s
specification, and can be used to compare systems. If the image is to be
used for localisation purposes then the magnitude of any distortion or
scaling error becomes important.
Frequency: At acceptance
Equipment: Phantom with rectangular array of aluminium spheres
36
6 Dosimetry for digital breast tomosynthesis
6.1 Introduction to DBT dosimetry
The procedures for estimating average glandular dose provided here for tomosynthesis systems
are an extension to the procedure followed in 2D mammography and are described more fully in
Dance et al 2011. A distinction is made between systems that have:
a full field detector and a X-ray tube that rotates above it so that the whole breast is irradiated in
each exposure over a range of angles (full field geometry)
or
a narrow scanning beam which scans across the breast as the X-ray tube rotates, and for which
the breast is only partially irradiated at each position of the X-ray tube (scanning geometry)
More information on both geometries is given in the Introduction.
Tables 1 to 10 referred to below are given in appendix I.
6.1.1 Full field geometry

In breast tomosynthesis, the average glandular dose (AGD) is the sum of the doses received from
individual projections. For each projection angle equation (10) can be used to estimate the
average glandular dose D(
D   Kgcs t   (10)
In this expression K is the incident air kerma at the top surface of the breast (without backscatter
from the breast), determined for the zero degree (straight through) position using the current-
time product (mAs) for angle The quantities g, c, s and t() are conversion factors. The factor
g gives the AGD for a breast of glandularity 50% and is tabulated against breast thickness and
HVL. The factor c allows for breasts of different glandularity and is tabulated against HVL and
breast thickness for typical breast compositions. The factor s allows for the use of different X-ray
spectra. Thus the first four quantities on the right hand side of the equation match the formalism
used for dosimetry of conventional (2D) mammography introduced by Dance et al (2000) which
is used in the European protocol. The final factor in the equation, t(), is the tomo factor for
projection angle Tabulations of the four factors are provided in Appendix I Tables 1-8. Data
are given as a function of breast thickness and of PMMA thickness (for use when breasts are
simulated with PMMA). The original publications of Dance (1990) and Dance et al (2000, 2009
and 2011) may be consulted for more information.
For a complete tomosynthesis examination the breast dose DT can be found from
DT  KT gcs T (11)
with
T    i t i  (12)
i
37
Here the summation is over all the projections for the examination and the αi give the partition of
the total current-time product (mAs) between the different projections. The incident air kerma KT
is measured in the ‘zero degree’ position, but is for the total mAs for the examination. If current-
time product (mAs) for each projection is the same, the expression for T in equation (12)
becomes:
 t  
1
T i
(13)
N i
where N is the number of projections. With knowledge of the projection angles  and the
weights αi the factor T can be calculated, using the data in appendix I Table 8. For a given data
set, this calculation only needs to be done once for each breast thickness. In calculating T, it is
important to remember that the data in Appendix I Table 8 are tabulated as a function of the
projection angle , not the tube rotation angle φ. The relationship between the two angles is:
 d sin  
    sin 1   (14)
 r 
where r is the distance from the focal spot to the centre of rotation and d is the distance from the
centre of rotation to the detector.
Appendix Table 9 gives values of T calculated from Appendix Table 8 using equation (12) and is
for use when the current-time-product (mAs) is the same for each projection and the angular
increment between successive projections is the same. Appendix I Table 10 gives values of T
which may be used for commercially available DBT systems. Updated versions of Appendix I
Table 10 will be made available on the EUREF website as new equipment becomes available.
It should be noted that the actual geometry simulated in Dance et al (2011) had a radiation field
matched to the image receptor size of 300x240 mm2, the image receptor was 660 mm from the
focal spot in the zero degree position, and the top of the breast support and the rotation axes were
15 mm and 40 mm respectively above the image receptor. As shown in the above paper, the
values of t(θ) are insensitive to changes in the positions of the rotation axis and the focal spot
receptor distance in the ‘zero degree’ position. Changes of ±40 mm in either of these parameters
produced a change in t(θ) of 2.3% or less, with smaller changes in T.
6.1.2 Scanning geometry

The receptor of the currently available scanning breast tomosynthesis system has a reduced
width (in this case 50 mm) and in order to image the whole breast, it rotates with the X-ray tube.
For any given position of the X-ray tube only a small fraction of the breast is irradiated. The
relationship between the air kerma measured in the ‘zero degree’ position and the average
glandular dose (DS) is then sensitive to the beam width and the imaging geometry, and a slightly
different formalism is therefore used.
In this case, normalisation is made to a measurement of air kerma made for a complete scanning
movement. Equation (15) is used:
DS  K S gcs TS (15)
38
Thus the air kerma KS is determined for a complete scan of the system at the same current-time
product (mAs) as the patient exposure, but without the breast.
The value of TS is dependent on the position of the dose meter and the breast thickness and must
be calculated separately for each scanning system geometry. Values of TS are provided in Dance
et al (2011) for measurements made with a dosimeter positioned on the upper surface of the
breast support.
In summary the method of determining the AGD for the scanning tomosynthesis systems is the
same as for fixed detector tomosynthesis systems except that
(a) Equation (15) is used
(b) The dose meter must be placed on the breast support table as the results are sensitive to
the height of the dose meter above the breast support
(c) The incident air kerma Ks is determined using a full scan as for a patient examination
rather than for a fixed 0º exposure
Appendix I Table 10 provides values of TS for the Philips Microdose system.
6.2 Assessing Average Glandular Dose
6.2.1 Assessing AGD using the standard breast model simulated with PMMA
The doses to a range of typical breasts could be assessed using blocks of PMMA as breast
substitutes and allowing the AEC to determine the exposure factors including any automatic
selection of kV and target/filter combination and current-time product (mAs). This method relies
on the equivalence in attenuation between different thicknesses of PMMA and typical breasts
[Dance et al, 2000] as listed in Appendix 1 tables 1 and 2. It should be noted that since PMMA is
denser than breast tissue any automatic selection of kV, target or filter may be slightly different
from real breasts. This may be corrected by adding spacers (e.g. expanded polystyrene blocks) to
the PMMA to make up a total thickness equal to the equivalent breast. Small pieces of more
attenuating materials can also be used as spacers provided they are outside the sensitive area of
the AEC. On systems that determine the exposure factors using transmission, spacers should not
be necessary.
Set the AEC to the normally used clinical settings and expose PMMA slabs of 20 mm thickness.
Record the exposure factors chosen by the AEC. Repeat for 30, 40, 45, 50, 60 and 70 mm
PMMA thickness.
39
Calculate the average glandular dose to a typical breast of thickness and composition equivalent
to the thickness of PMMA by applying equation 11 or 15 as appropriate. Note that the c and g-
factors applied are those for the corresponding thickness of typical breast rather than the
thickness of PMMA block used. Where necessary interpolation may be made for different values
of HVL. Typical values of HVL for various spectra are given in Appendix I Table 3 but HVLs
are normally measured at the same time as the measurements necessary to determine the incident
air kerma. The factor s shown in Appendix I Table 4 corrects for any difference due to the
choice of X-ray spectrum (Dance et al 2000, 2009 and 2011). For W/Al target/filter
combinations the s-factor is tabulated against the thickness of breasts and PMMA. K (or KS) is
the incident air kerma (without backscatter) calculated at the upper surface of the PMMA
using the method described below. Appendix I Table 10 gives values of T and TS which may be
used for commercially available DBT systems. Updated versions of Appendix I Table 10 will be
made available on the EUREF website as new equipment becomes available.
The determination of incident air kerma at the surface of PMMA test phantoms should be based
on measurements made with a geometry which includes scatter from the paddle. It is advisable to
place a thin steel plate on the breast support to fully cover the imaging detector to prevent ghost
images of the dosimeter in subsequent images.
Compression
paddle
Dosimeter
Dosimeter
60 mm
60 mm
distance to
chest wall side
Figure 11a Position of dosimeter to determine the incident air kerma for dose estimation, top view and 3D-
view.
40
X-ray tube
focal spot
Compression
paddle
Compression Dosimeter Dosimeter

paddle
Figure 11b Position of dosimeter to determine the incident air kerma for dose estimation, front and side view.
The dose meter should be positioned on a line extending from the tube focal spot to a point on
the mid-line of the breast support table 60 mm from the chest wall edge. If the dose meter has
back scatter correction, the recommended position for a full field imaging geometry is directly
on the breast support (or the steel sheet covering it – see above) with the paddle in contact
(Figure 11). For a scanning geometry, this position is mandatory (see above), and if necessary a
correction for backscatter would need to be applied. For a full field imaging geometry, it would
also be possible to make a measurement of air kerma with the dosimeter higher above the breast
support and with the paddle in contact provided appropriate inverse square law correction is
made. This approach is recommended if the dose meter does not have backscatter correction.
The effect of scatter from the compression paddle on the measurement of incident air kerma is
discussed in Dance et al 2009 where it is shown that for the above geometry, and a
polycarbonate paddle 2.4 mm thick scattered photons contribute 7% of the total measured air
kerma. For some designs of dosimeter, a small correction to the dosimeter reading may be
necessary because of variation of the dosimeter response with angle.
Calculate the incident air kerma for each of the beam qualities used in exposing the blocks of
PMMA by making an exposure of the dosimeter positioned as discussed above using a manually
selected current-time product (e.g. 50 mAs) and the tube fixed at the ‘zero degree’ position.
Estimate the incident air kerma at the upper surface of the PMMA by using the inverse square
law and scaling to the appropriate value of current-time product (mAs).
41
6.2.2 Assessing clinical breast doses
It is also possible to measure the average glandular dose for a series of breast examinations on
each mammography system. To do this, for each exposure the breast thickness under
compression is measured, and the exposure factors are recorded. From measurements of air
kerma as described above at the tube voltage and target/filter combination used, the current-time
product (mAs) may be used to estimate the incident air kerma and to determine the average
glandular dose using equations 11 or 15 as appropriate. In this case the incident air kerma K (or
KS) is calculated at the upper surface of the breast. g-factors should be interpolated for the
appropriate breast thickness from Appendix I Table 5. c-factors for typical breast compositions
in the age ranges 50 to 64 and 40 to 49 are shown in Appendix I Tables 6 and 7. The compressed
thickness on the X-ray set should be recorded. The accuracy of the displayed thickness should be
verified by applying a typical force (e.g. 100 N) to a block of compressible foam (dimensions
180mm x 240mm) in which a strip has been cut out to allow measurement of compressed
thickness, see figure 12. Record the thickness indication and measure thickness at the reference
point with an appropriate device (for example a compass). Perform this measurement of several
blocks of foam such that the thicknesses from 20 to 100 mm can be verified
Bucky
foam block
Fig. 12 The position of the foam block on the bucky
It may be necessary to apply correction factors if the displayed values are in error. An accuracy
of  2 mm is required (Faulkner and Cranley, 2005). Appendix I Table 10 gives values of T and
TS which may be used for commercially available DBT systems. Updated versions of Appendix I
Table 10 will be made available on the EUREF website as new equipment becomes available.
The data in Appendix I Tables 9-11 have been calculated for a standard breast model examined
in the CC-view. The values of t() for the MLO view are quite different (Sechopoulos et al,
2007), but after integration, the resulting values of T for MLO and CC views are similar, and
provided the weights for each projection angle are the same, for practical purposes, the T-factors
for the CC-projection can be used (Dance et al, 2011).
42
Reference value: To be determined. It is advised to use the limiting values of the European
Guidelines as reference value, see table 3.
Table 3 Reference values for AGD at different thicknesses for tomosynthesis X-ray units or tomosynthesis
mode on mammographic X-ray units (if FFDM imaging is possible).
Thickness of PMMA Equivalent breast thickness Average glandular dose to equivalent

breasts
Reference level level
(mm) (mm) (mGy)
20 21 1.0
30 32 1.5
40 45 2.0
45 53 2.5
50 60 3.0
60 75 4.5
70 90 6.5

Equipment: Suitable dose meter, blocks of foam of several thicknesses
43
7 Image presentation
The tests in this section are based upon the work of AAPM TG18 (American Association of
Physicists in Medicine, Task Group 18). The TG18 test patterns described in this section should
be downloaded from the TG18 website (2k versions should be used when available):
http://deckard.mc.duke.edu/~samei/tg18. Some mammography display systems need adjusted
versions of the test patterns, these are available from the EUREF website.
Some general remarks:

- The test patterns have to be displayed at full resolution (exactly one display pixel for each pixel
in the digital image) or printed at full size; contrast and brightness of the images may not be
adjusted.
- For the tests in this chapter, the use of the display (primary class (diagnostic) or secondary class
display device) often determines the limiting values.
- Some of the tests in this chapter are for Cathode Ray Tube (CRT) displays or Liquid Crystal
Displays (LCDs) only.
- A magnifying glass may be used in the evaluation of printed images
- The monitors should be tested as used clinically (e.g. third monitor on, viewing boxes on
covered with films)
7.1 Monitors
7.1.1 Ambient light
Most of the quality tests in this chapter are highly sensitive to ambient light, therefore all of them
should be performed under clinical conditions (room lights, light boxes and other display devices
should be at the same luminance level as under clinical conditions). The ambient light should be
measured at the centre of the display with the light detector facing outwards and the display
switched off.
Limiting value Ambient light should be less than 20 lux for primary display
devices. [The maximum ambient light actually depends on
the reflection characteristics and minimum luminance of the
monitor, but for reasons of simplicity this is ignored here.]
Frequency Every six months. (Every time the system is used, it has to be
made sure that ambient light conditions have not changed.)
Equipment Illuminance meter
7.1.2 Geometrical distortion (CRT displays)

Visually check whether the TG18-QC image (figure 13) is displayed without geometrical
distortion. To do so, inspect the lines and borders of the test pattern.
44
Figure 13 TG18-QC test pattern
Limiting value Borders should be completely visible, lines should be

straight, the active display area should be centred on the
screen
Frequency Daily
Equipment TG18-QC test pattern
7.1.3 Contrast visibility

The TG18-QC test pattern contains several items for evaluating the contrast visibility of a
display.
Each of the sixteen luminance patches, located approximately equidistant from the centre of the
image, contains four corner squares at equal low contrast steps to the patch (figure 14). The two
patches in the bottom with minimum and maximum pixel value, surrounding the test pattern
name, contain a centre square with a pixel value of 5% and 95% of the maximal grey level
respectively. The letters “QUALITY CONTROL” in the three rectangles below these patches are
displayed with decreasing contrast to the background. The visible part of the letters should be
written down and checked with the visibility at acceptance, in order to keep track of contrast
degradation. If contrast visibility is not sufficient, it may help to dim the room lights. If this is
done however, the lights should also be dimmed while using the displaying system clinically.
The appearance of the TG18-QC test pattern also depends on the mapping of pixel values to
luminance. Therefore if this test has failed, the tests in sections 7.1.6 and 7.1.7 should be
performed.
Remark: It should be kept in mind that the luminance of LCD monitors depends on the viewing
angle. When large viewing angles are used, contrast visibility may not comply with the limiting
values.
45
Figure 14 Contrast visibility test items in TG18-QC test image
Limiting value All corner patches should be visible, the 5% and 95% pixel
value squares should be clearly visible
Frequency Daily
Equipment TG18-QC test pattern
46
7.1.4 Resolution
Evaluate horizontal and vertical line patterns to check display resolution visually.
AAPM Task Group 18 provides 6 line patterns at different background luminance levels.
(Horizontal line patterns TG18-LPH10, -LPH50 and –LPH89; Vertical line patterns TG18-
LPV10, -LPV50 and –LPV89.)
Figure 15 Zoomed versions of the TG18-LPH50 pattern
Limiting value All line patterns should be discernible

Frequency Every 6 months
Equipment 2kx2k TG18-LPH10, TG18-LPH50, TG18-LPH89, TG18-
LPV10, TG18-LPV50 and TG18-LPV89 test patterns
7.1.5 Display artefacts

The TG18-QC test pattern also contains some elements, which can be used for recognising
display artefacts. The image should be carefully checked for defect pixels (LCD only), steps in
the black-to-white and white-to-black ramp bars (this can reveal an insufficient bit depth), and
artefacts near the black-to-white and white-to-black transitions (video card). Also pay attention
to temporal instability (flicker) and spatial instability (jitter).
Limiting Values No disturbing artefacts should be visible

Frequency Daily
Equipment 2kx2k TG18-QC test pattern
47
7.1.6 Luminance range
Measure the maximum and minimum luminance of the display device. Test patterns TG18-
LN12-01 and TG18-LN12-18 can be used.
The ratio of maximum and minimum display luminance, in the presence of ambient light, is an
indicator of luminance contrast response capabilities of the monitor (under the current
environmental conditions). Both luminances should be measured using a telescopic luminance
meter, to include the influence of ambient light.
The ratio can be increased by reducing ambient light or by display adjustments. DICOM GSDF
conformance (section 4.1.7) makes sure the available contrast is spread out in an appropriate and
standard manner over the full greyscale range of the monitor.
angle. When large viewing angles are used, the luminance range may not comply with the
limiting values.
Limiting Values The maximum to minimum luminance ratio should be at least

350 for primary display devices1, or 100 for secondary
display devices. The maximum luminance should exceed 500
cd/m2. The difference of maximum luminances between
displays belonging to one displaying station should not
exceed 5% of the lowest.
Frequency Every six months or when contrast visibility has changed
Equipment Telescopic luminance meter, TG18-LN12-01 and TG18-
LN12-18 test patterns
7.1.7 Greyscale Display Function

To make sure a mammogram will appear similarly on different viewing stations and on printed
film, the mapping of greyscale values to display luminance or optical density should be
consistent. In this measurement it is determined whether a display conforms to the DICOM
Greyscale Standard Display Function (GSDF).
The greyscale display function (GDF) can be determined by measuring the luminance of the 18
AAPM luminance test patterns (TG18-LN12-01 through TG18-LN12-18). The test patterns
should be displayed full screen and the luminance has to be measured at the centre of the screen.
The shape of the GDF depends on the ambient light in the room. Therefore room lights, light
boxes and other display devices should be at the same luminance level as when the system is
used clinically. A telescopic luminance meter should be used to include the influence of ambient
light.
The measured values can be inserted into a spreadsheet (available on the Euref website:
www.euref.org ) to automatically determine GSDF conformance.
1
Note that the limiting value for this maximum to minimum luminance ratio has been changed compared to the
fourth edition of the Guidelines.
48
After doing this measurement, the amount of ambient light may not be increased anymore,
otherwise the contrast response has to be measured again!
Remark: This test only applies to primary and secondary display systems. The acquisition
workstation monitor is excluded from this test. Due to the required ambient light levels in the
mammography room the acquisition workstation monitor will not comply with the limiting
values of primary and secondary displays. Therefore this monitor should only be used to check
positioning techniques, not for diagnosis and image quality checks.
angle. When large viewing angles are used, the display on a monitor may not comply with the
GSDF.
Limiting value The calculated contrast response should fall within  10% of the GSDF
contrast response for primary class displays ( 20% for secondary class
displays)
Frequency Every six months and when contrast visibility has changed
Equipment Telescopic luminance meter, TG18-LN12-01 through TG18-LN12-18 test
patterns
7.1.8 Luminance uniformity

When the display has been tested for DICOM conformance at the centre of the monitor, this does
not mean contrast visibility is optimal at every position on the monitor. One could test the GDF
for several locations on the monitor, but it is more convenient to check display uniformity.
Measure the display luminance at five locations for each monitor. The test patterns TG18-
UNL10 and TG18-UNL80 can be used (figure 16).
Figure 16 TG18-UNL10 and TG18-UNL80
test patterns
49
Limiting value Maximum luminance deviation of a display device should be
less than 30% for CRT displays and LCD displays
((Lmax-Lmin)/Lcentre<0.3).
Frequency Every six months and when contrast visibility has changed
Equipment Luminance meter (telescopic luminance meters should be
equipped with a cone or baffle for this measurement), TG18-
UNL10 and TG18-UNL80 test patterns
2b.4.1.2 - 5 Alternative: Constancy test of monitor performance

In the following section we describe alternative test patterns that allow to test contrast visibility,
distortion and artefacts as efficient as with the AAPM test patterns (Jacobs 2007). The complete
procedure includes the generation of an always new test pattern at every evaluation and a fill-in
sheet of which the readings are compared to the truth. This overcomes inattentive scorings and
allows an easy verification of adherence to the Quality Control procedures. The software to
create and score the test patterns is downloadable via the EUREF website.
The pattern is divided in four equally sized, rectangular segments with four uniform background
values of different intensities. The values were chosen to be 0%, 33%, 66% and 100% of the
maximum gray level. The position of these rectangles swaps randomly each time the pattern is
generated with one restriction: the rectangle with a gray level of 0% (Lmin) will always have a
mutual border with the rectangle with a gray level of 100% (Lmax). This guarantees the creation
of a black-to-white or white-to-black transition between the patches with the highest and the
lowest gray level. This transition can be either horizontal or vertical. Figure 9 shows two
examples of the variable pattern.
Figure 17 Two examples of the MoniQA pattern. These patterns include checks for contrast visibility,
geometric distortion, spatial resolution, global image quality and artifacts. (reprinted with
permission from Med Phys)
Extra tests:
(a) Low contrast characters

50
In the center of each rectangular segment there is a set of five characters that creates a
low contrast with the background pixel value (Figure 10a). Each time the pattern is
created the characters are randomly chosen out of a subset of the Latin alphabet, namely
ABCDEHJKLMPSTUZ. Each set of characters has pixel value differences of 7, 5, 3, 2
and 1 between background and character. The observer has to read as many characters as
possible. We suggest that the observer guesses the value of one character more than what
he readily sees.
Score criteria: If characters are not discriminated from the background, points are
subtracted from the initial score of 100 according to the pixel value difference between
character and background. If the least visible character is not read, 1 point is deducted.
The next character has a value of two points; the third character has a value of three
points. For the fourth character, 5 points are deducted and if the highest contrast character
is not detectable 7 points are deducted.
(b) Gradient bar of patches with increasing pixel values and low contrast characters
In the center of the display, a gradient bar of 18 distinct grayscale steps is drawn, with
pixel values as used in the central rectangle of the AAPMtg18-LN patterns. This bar is
horizontal or vertical but will never divide the rectangles with 0% and 100% of the
maximum gray level. A random character is placed on each step of the gradient. The bar
is divided in 2 equally sized parts, a northern and southern part or a western and eastern
part. In each part of the gradient bar, each character is unique. For the selection of the
characters, we use the same alphabet as used for the selection of the low contrast
characters. The grayscale value of each character is the same as the grayscale value of the
preceding luminance patch (Figure 10b), with the whitest and darkest patches at the
extremes.
To evaluate this pattern, characters are to be read, starting in the middle and according to
the orientation of the bar, towards West, East, North and South. If a luminance character
is visible, we conclude that the underlying patch can be clearly distinguished from the
adjacent patch. In the AAPMtg18-QC and the DIN test pattern, the purpose of this
gradient bar is to verify whether the different steps are distinguishable. This is most
critical for the lowest and highest pixel values. When evaluating the MoniQA pattern,
only the two last visible characters have to be registered.
Score criteria: 10 points are deducted for each incorrectly identified or invisible low
luminance patch and this for both extremities of the gradient bar. If no character has been
filled in, 9 times 10 points are deducted.
(c) The MoniQA pattern allows to test geometric distortion, the fact whether all pixels of the
test image are shown, high and low contrast spatial resolution, and artefacts (black-to-
white and white-to-black transition problems. Any defects lower the score with 5 points,
except a dead pixel that lowers the score with 11 points.
51
Figure 18 – (a) example of a sequence of characters with a low contrast luminance difference with the
background – (b) gradient bar of patches with decreasing pixel values and with random
characters having a pixel value as in the adjacent patch – (c) grid pattern – (d) corner lines
pattern – (e) resolution patterns, left: high contrast, right: low contrast – (f) and (g) horizontal
and vertical version of the hourglass object
(all elements are shown with enhanced contrast for clarity)
52
The MoniQA pattern is highly variable. There are 16 combinations of background positions, 4
positions for the resolution pattern inside each background field and 2 resolution types (high and
low contrast) which makes a total number of 128 possible configurations. In addition, there is a
very large number of combinations of characters for the low contrast visibility checks.
Limiting value Score retrieved from MoniQA pattern should be higher or equal to 95
Frequency Daily, optional weekly
Equipment MoniQA test pattern
53
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55
Appendix I. Tables for dosimetry calculation in digital breast tomosynthesis
Table 1 g-factors for breasts simulated with PMMA
Equiv. Gland. g-factors (mGy/mGy)

PMMA of
breast
thickness HVL (mm Al)
thickness equiv.
(mm) breast
(mm) 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80
(%)
20 21 97 0.378 0.421 0.460 0.496 0.529 0.559 0.585 0.609 0.631 0.650 0.669
30 32 67 0.261 0.294 0.326 0.357 0.388 0.419 0.448 0.473 0.495 0.516 0.536
40 45 41 0.183 0.208 0.232 0.258 0.285 0.311 0.339 0.366 0.387 0.406 0.425
45 53 29 0.155 0.177 0.198 0.220 0.245 0.272 0.295 0.317 0.336 0.354 0.372
50 60 20 0.135 0.154 0.172 0.192 0.214 0.236 0.261 0.282 0.300 0.317 0.333
60 75 9 0.106 0.121 0.136 0.152 0.166 0.189 0.210 0.228 0.243 0.257 0.272
70 90 4 0.086 0.098 0.111 0.123 0.136 0.154 0.172 0.188 0.202 0.214 0.227
80 103 3 0.074 0.085 0.096 0.106 0.117 0.133 0.149 0.163 0.176 0.187 0.199
Table 2 c-factors for breasts simulated with PMMA
PMMA Equiv. Gland.of c-factors

thickness breast equiv.
(mm) thickness breast HVL (mm Al)
(mm) (%)
0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80
20 21 97 0.889 0.895 0.903 0.908 0.912 0.917 0.921 0.924 0.928 0.933 0.937
30 32 67 0.940 0.943 0.945 0.946 0.949 0.952 0.953 0.956 0.959 0.961 0.964
40 45 41 1.043 1.041 1.040 1.039 1.037 1.035 1.034 1.032 1.030 1.028 1.026
45 53 29 1.109 1.105 1.102 1.099 1.096 1.091 1.088 1.082 1.078 1.073 1.068
50 60 20 1.164 1.160 1.151 1.150 1.144 1.139 1.134 1.124 1.117 1.111 1.103
60 75 9 1.254 1.245 1.235 1.231 1.225 1.217 1.207 1.196 1.186 1.175 1.164
70 90 4 1.299 1.292 1.282 1.275 1.270 1.260 1.249 1.236 1.225 1.213 1.200
80 103 3 1.307 1.299 1.292 1.287 1.283 1.273 1.262 1.249 1.238 1.226 1.213
56
Table 3 Typical HVL measurements for different tube voltage and target filter combinations. (Data
includes the effect on measured HVL of attenuation by a compression paddle.)
HVL (mm Al) for target filter combination

kV Mo Mo Mo Rh Rh Rh W Rh W Ag W Al W Al
(0.5mm) (0.7mm)
25 0.32  .02 0.38  .02 0.37  .02 0.50  .03 0.51  .03 0.34  .03 0.42  .03
28 0.35  .02 0.42  .02 0.42  .02 0.53  .03 0.58  .03 0.39  .03 0.49  .03
31 0.38  .02 0.45  .02 0.45  .02 0.56  .03 0.61  .03 0.44  .03 0.55  .03
34 0.40  .02 0.47  .02 0.47  .02 0.59  .03 0.64  .03 0.49  .03 0.61  .03
37 0.62  .03 0.67  .03 0.53  .03 0.66  .03
42
Table 4a s-factors for clinically used spectra [Dance et al 2000, 2009, 2011].
Target material Filter material Filter thickness (m) s-factors

Mo Mo 30 1.000
Mo Rh 25 1.017
Rh Rh 25 1.061
W Rh 50-60 1.042
W Ag 50-75 1.042
Table 4b s-factors for a tungsten target filtered by 0.5 mm aluminium [Dance et al 2000, 2009, 2011].
PMMA Equiv breast s-factor

thickness thickness
(mm) (mm)
20 21 1.075
30 32 1.104
40 45 1.134
45 53 1.149
50 60 1.160
60 75 1.181
70 90 1.198
80 103 1.208
57
Table 4c s-factors for a tungsten target filtered by 0.7 mm aluminium. This table is an extension of the data
published in Dance et al 2000, 2009, 2011.
PMMA Equiv breast s-factor

thickness thickness
(mm) (mm)
20 21 1.052
30 32 1.064
40 45 1.082
45 53 1.094
50 60 1.105
60 75 1.123
70 90 1.136
80 103 1.142
Table 4d s-factors for a tungsten target filtered by 0.5 mm aluminium[Dance et al 2000, 2009, 2011].
Breast Glandularity Typical Typical kV range s-factor

thickness range glandularity glandularity (kV)
(mm) (%) age 50-64 age 40-49
20 80-100 100 100 25-40 1.069

30 62-82 72 82 29-40 1.104
40 40-65 50 65 29-40 1.127
50 23-49 33 49 30-40 1.139
60 11-35 21 35 30-40 1.154
70 2-24 12 24 30-40 1.180
80 0.1-17 7 14 30-40 1.187
90 0.1-14 4 8 30-40 1.198
100 0.1-13 3 5 30-40 1.206
110 0.1-13 3 5 30-40 1.212
58
Table 4e s-factors for a tungsten target filtered by 0.7 mm aluminium.
Breast Glandularity Typical Typical kV range s-factor

thickness range glandularity glandularity (kV)
(mm) (%) age 50-64 age 40-49
20 80-100 100 100 25-50 1.052
30 62-82 72 82 25-50 1.060
40 40-65 50 65 25-50 1.076
50 23-49 33 49 25-50 1.087
60 11-35 21 35 25-50 1.105
70 2-24 12 24 28-50 1.121
80 0.1-17 7 14 28-50 1.129
90 0.1-14 4 8 28-50 1.136
100 0.1-13 3 5 28-50 1.140
110 0.1-13 3 5 28-50 1.144
Table 5 g-factors (mGy/mGy) for breast thicknesses of 20-110 mm and the HVL range 0.30-0.60 mm Al.
The g-factors for breast thicknesses of 20-80 mm are taken from Dance (1990), and for 90-110
mm from Dance et al (2000 & 2011).
Breast HVL mm Al
thickness
(mm) 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80
20 0.390 0.433 0.473 0.509 0.543 0.573 0.587 0.622 0.644 0.663 0.682
30 0.274 0.309 0.342 0.374 0.406 0.437 0.466 0.491 0.514 0.535 0.555
40 0.207 0.235 0.261 0.289 0.318 0.346 0.374 0.399 0.421 0.441 0.460
50 0.164 0.187 0.209 0.232 0.258 0.287 0.310 0.332 0.352 0.371 0.389
60 0.135 0.154 0.172 0.192 0.214 0.236 0.261 0.282 0.300 0.317 0.333
70 0.114 0.130 0.145 0.163 0.177 0.202 0.224 0.244 0.259 0.274 0.289
80 0.098 0.112 0.126 0.140 0.154 0.175 0.195 0.212 0.227 0.241 0.254
90 0.0859 0.0981 0.1106 0.1233 0.1357 0.1543 0.1723 0.1879 0.2017 0.2143 0.2270
100 0.0763 0.0873 0.0986 0.1096 0.1207 0.1375 0.1540 0.1682 0.1809 0.1926 0.2044
110 0.0687 0.0786 0.0887 0.0988 0.1088 0.1240 0.1385 0.1520 0.1638 0.1746 0.1856
59
Table 6 c-factors for average breasts for women in age group 50 to 64 (Dance et al 2000 & 2011)
Breast Gland. HVL (mm Al)

thickness
(mm) % 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80
20 100 0.885 0.891 0.900 0.905 0.910 0.914 0.919 0.923 0.928 0.932 0.936
30 72 0.925 0.929 0.931 0.933 0.937 0.940 0.941 0.947 0.950 0.953 0.956
40 50 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000
50 33 1.086 1.082 1.081 1.078 1.075 1.071 1.069 1.064 1.060 1.057 1.053
60 21 1.164 1.160 1.151 1.150 1.144 1.139 1.134 1.124 1.117 1.111 1.103
70 12 1.232 1.225 1.214 1.208 1.204 1.196 1.188 1.176 1.167 1.157 1.147
80 7 1.275 1.265 1.257 1.254 1.247 1.237 1.227 1.213 1.202 1.191 1.179
90 4 1.299 1.292 1.282 1.275 1.270 1.260 1.249 1.236 1.225 1.213 1.200
100 3 1.307 1.298 1.290 1.286 1.283 1.272 1.261 1.248 1.236 1.224 1.211
110 3 1.306 1.301 1.294 1.291 1.283 1.274 1.266 1.251 1.240 1.228 1.215
Table 7 c-factors for average breasts for women in age group 40 to 49 (Dance et al 2000 & 2011)
Breast Gland. HVL (mm Al)

thickness
(mm) % 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80
20 100 0.885 0.891 0.900 0.905 0.910 0.914 0.919 0.923 0.928 0.932 0.936
30 82 0.894 0.898 0.903 0.906 0.911 0.915 0.918 0.924 0.928 0.933 0.937
40 65 0.940 0.943 0.945 0.947 0.948 0.952 0.955 0.956 0.959 0.961 0.964
50 49 1.005 1.005 1.005 1.004 1.004 1.004 1.004 1.004 1.003 1.003 1.003
60 35 1.080 1.078 1.074 1.074 1.071 1.068 1.066 1.061 1.058 1.055 1.051
70 24 1.152 1.147 1.141 1.138 1.135 1.130 1.127 1.117 1.111 1.105 1.098
80 14 1.220 1.213 1.206 1.205 1.199 1.190 1.183 1.172 1.163 1.154 1.145
90 8 1.270 1.264 1.254 1.248 1.244 1.235 1.225 1.214 1.204 1.193 1.181
100 5 1.295 1.287 1.279 1.275 1.272 1.262 1.251 1.238 1.227 1.215 1.203
110 5 1.294 1.290 1.283 1.281 1.273 1.264 1.256 1.242 1.232 1.220 1.208
60
Table 8a t-factors (breast thickness) for the calculation of AGD for individual projections and the full field
geometry.
Breast Conversion factor t

thickness for Projection angle (degrees)
(mm) 5 10 15 20 25 30
20 0.997 0.988 0.976 0.958 0.930 0.895
30 0.996 0.986 0.970 0.944 0.914 0.870
40 0.996 0.984 0.964 0.937 0.902 0.859
50 0.995 0.983 0.961 0.932 0.897 0.855
60 0.994 0.980 0.960 0.926 0.894 0.851
70 0.993 0.980 0.956 0.927 0.894 0.851
80 0.993 0.979 0.955 0.924 0.892 0.852
90 0.991 0.977 0.951 0.924 0.892 0.854
100 0.993 0.975 0.949 0.924 0.892 0.845
110 0.992 0.973 0.947 0.921 0.888 0.834
Table 8b t-factors (PMMA thickness) for the calculation of AGD for individual projections and the full
field geometry.
PMMA Equivalent Conversion factor t

Thickness breast for projection angle (degrees)
thickness
(mm) (mm) 5 10 15 20 25 30
20 21 0.997 0.988 0.975 0.956 0.928 0.893
30 32 0.996 0.985 0.968 0.942 0.911 0.868
40 45 0.996 0.984 0.963 0.934 0.900 0.857
45 53 0.995 0.982 0.961 0.930 0.896 0.854
50 60 0.994 0.980 0.960 0.926 0.894 0.851
60 75 0.993 0.980 0.955 0.925 0.893 0.851
70 90 0.991 0.977 0.951 0.924 0.892 0.854
80 103 0.993 0.974 0.948 0.923 0.891 0.842
61
Table 9a T-factors (breast thickness) for different scan ranges and the full field geometry.
Breast Conversion factor T

thickness for projection angular range of (degrees)
(mm) -10 to +10 -15 to +15 -20 to +20 -25 to +25 -30 to +30
20 0.994 0.989 0.982 0.972 0.960
30 0.992 0.985 0.976 0.965 0.950
40 0.992 0.984 0.973 0.961 0.944
50 0.991 0.982 0.971 0.957 0.941
60 0.989 0.981 0.969 0.955 0.939
70 0.989 0.980 0.969 0.955 0.940
80 0.988 0.979 0.967 0.953 0.937
90 0.987 0.977 0.965 0.952 0.937
100 0.987 0.977 0.965 0.952 0.935
110 0.986 0.975 0.963 0.949 0.931
Table 9b T-factors (PMMA thickness) for different scan ranges and the full field geometry.
PMMA Equivalent Conversion factor T

thickness breast for projection angular range of (degrees)
thickness
(mm) (mm) -10 to +10 -15 to +15 -20 to +20 -25 to +25 -30 to +30
20 21 0.993 0.988 0.981 0.971 0.959
30 32 0.992 0.985 0.976 0.964 0.949
40 45 0.992 0.983 0.972 0.959 0.943
45 53 0.991 0.982 0.970 0.956 0.940
50 60 0.989 0.981 0.969 0.955 0.939
60 75 0.989 0.980 0.968 0.954 0.938
70 90 0.987 0.977 0.965 0.952 0.937
80 103 0.987 0.976 0.964 0.951 0.934
62
Table 10a T-factors (breast thickness) for the following full field tomosynthesis systems (geometry and
exposure values as in table 1): Hologic Selenia Dimensions (2011 model), Siemens Mammomat
Inspiration tomographic system (2011 model), GE Essential (2013 model), IMS Giotto TOMO
(2013 model) and Planmed Nuance Excel DBT (2013 model). Updated versions of Table 10a will
be made available on the EUREF website as new equipment becomes available.
Breast TFujifilm TFujifilm TGE THologic TIMS TPlanmed TSiemens

thickness ± 7.5° ± 20° ± 12.5° ± 7.5° ± 19° ± 15° ± 24°
(mm)
20 0.997 0.985 0.993 0.997 0.985 0.991 0.980
30 0.996 0.981 0.991 0.996 0.981 0.989 0.974
40 0.997 0.979 0.990 0.996 0.978 0.988 0.971
50 0.996 0.977 0.989 0.995 0.976 0.986 0.968
60 0.995 0.975 0.988 0.994 0.974 0.985 0.966
70 0.995 0.974 0.987 0.994 0.973 0.984 0.965
80 0.994 0.972 0.986 0.993 0.972 0.983 0.964
90 0.993 0.971 0.985 0.992 0.970 0.981 0.962
100 0.994 0.970 0.984 0.993 0.970 0.981 0.961
110 0.993 0.969 0.984 0.992 0.968 0.980 0.960
Table 10b TS factors (breast thickness) for the Philips Microdose system with scanning geometry (geometry
and exposure values from 2010 prototype). Updated versions of Table 10b will be made available
on the EUREF website as new equipment becomes available.
Breast thickness TPhilips

(mm)
20 0.983
30 0.958
40 0.935
50 0.907
60 0.883
70 0.859
80 0.833
90 0.806
100 0.783
110 0.759
63
Table 11a T-factors (PMMA thickness) for the following full field tomosynthesis systems: Hologic Selenia
Dimensions (geometry and exposure values for 2011 model), Siemens Mammomat Inspiration
tomographic system (geometry and exposure values for 2011 model), GE Essential, IMS Giotto
TOMO and Planmed Clarity. Updated versions of Table 11a will be made available on the
EUREF website as new equipment becomes available.
PMMA Breast TFujifilm TFujifilm TGE THologic TIMS TPlanmed TSiemens

thickness thickness ± 7.5° ± 20° ± 12.5° ± 7.5° ± 19° ± 15° ± 24°
(mm) (mm)
20 21 0.997 0.985 0.993 0.997 0.985 0.991 0.979
30 32 0.996 0.980 0.991 0.996 0.980 0.988 0.973
40 45 0.996 0.978 0.990 0.996 0.977 0.987 0.969
45 53 0.995 0.976 0.989 0.995 0.976 0.986 0.968
50 60 0.995 0.975 0.988 0.994 0.974 0.985 0.966
60 75 0.994 0.973 0.987 0.994 0.973 0.984 0.964
70 90 0.993 0.971 0.985 0.992 0.970 0.981 0.962
80 103 0.994 0.969 0.984 0.993 0.969 0.980 0.961
Table 11b TS factors (PMMA thickness) for the Philips Microdose system with scanning geometry (geometry
and exposure values from 2010 prototype). Updated versions of Table 11b will be made available
on the EUREF website as new equipment becomes available.
PMMA Breast TPhilips

thickness thickness
(mm) (mm)
20 21 0.980
30 32 0.953
40 45 0.921
45 53 0.900
50 60 0.883
60 75 0.846
70 90 0.806
80 103 0.776
64
Appendix II Noise Power Spectrum (NPS)
Appendix II.1 NPS in the x-y plane
The use of linear system theory metrics on reconstructed planes is under debate. However it is
clear that the noise properties of different tomosynthesis systems differ substantially, much more
than with current FFDM systems. Therefore an objective measurement of noise seems important.
Currently measuring NPS can be performed to ensure stability of the tomosynthesis system and
similar settings on several systems of the same type.
Under development:
Method: Select manual exposure mode, typical DBT anode/filter combination and tube voltage,
position a 2 mm thick aluminium plate as close as possible to the X-ray tube and set the
automatic exposure settings for the attenuation of 2 mm aluminium filter for this breast
thickness. Set compression height to 45 mm so that the system reconstructs a volume of 45 mm.
Acquire the DBT scan and reconstruct using the standard clinical reconstruction algorithm (this
is an air reconstruction with metal (Al) filtration; low scatter). Calculate the NPS from the 20
mm plane using the extraction method of Siewerdsen et al (2002). Use a standard NPS algorithm
(50 mm x 50 mm NPS region extracted from centre of x-y plane; detrend by fitting and
subtracting 2nd order polynomial from this region; 256 x 256 half-overlapping ROIs; section 0°
and 90° axes separately as the in-plane DBT NPS is probably non-isotropic) . Rebin to 0.25 mm-
1
spatial frequency bins. Record the NNPS at 0.5 mm-1 and 2 mm-1.
Remark: This method does not account for / include correlations orthogonal to the direction of
extraction. This can underestimate the true NPS if correlations are not accounted for in some
way. Correction could be made using a bandwidth integral.
Limiting values: To be determined
Equipment: 2 mm thick aluminium plate
Appendix II.2 NPS in the reconstructed tomosynthesis image

Under development.
65
Appendix III: Significance of test items
The test-items described in this protocol can be divided in three categories: essential test items
which should be measured, desirable test items which are advised to be measured, optional test
items which can be measured.
Essential test items: performed:

1.4 Tube output acc. May be performed in FFDM1
1.5.2 HVL acc. May be performed in FFDM1
1.6 Exposure distribution per projection image acc./routine For systems with variable dose
per projection
2.1 Back-up timer and security cut-off acc./routine
2.2 AEC Short term reproducibility acc./routine
2.3 AEC Long term reproducibility acc./routine
2.4 AEC performance acc./routine
3.1 Compression force acc./routine May be performed in FFDM
4.1.1 Response function acc./routine May be performed in FFDM1
4.1.2 Noise analysis acc./routine May be performed in FFDM1
4.2 Detector element failure acc./routine May be performed in FFDM2
4.3 Uncorrected defective detector elements acc./routine
5.1 Stability of image quality in the x-y plane acc./routine
Image quality test
5.2 Z-resolution acc./routine
5.5 Missed tissue acc./routine
5.6 Homogeneity of the reconstructed tomosynthesis image acc./routine
5.7 Geometric distortion acc.
6.2.1 Assessing AGD with PMMA acc./routine
6.2.2 Assessing clinical breast doses typetest
Desirable test items:

1.2 Focal spot motion acc./routine
1.3 Coincidence of reconstructed and irradiated volume acc./routine
2.5 Exposure time and total scan time acc./routine
4.5 System projection MTF acc./routine
5.7 Geometric distortion routine
6.2.2 Assessing clinical breast doses acc./routine
Optional test items:

1.1 Focal spot size acc.
1.5.1 Tube voltage acc./routine
1.6 Exposure distribution per projection image acc. For systems with equal dose
per projection
5.3 MTF in the x-y plane acc./routine
5.4 NPS in the x-y plane acc./routine
1
It must be verified whether the target, material and thickness of the filter and readout of the detector is equal in
FFDM and DBT mode.
2
It must be verified whether the readout of the detector is equal in FFDM and DBT mode.
66
Appendix IV Specifications and tolerances of equipment and phantoms
TableIV.1 Specifications and tolerances of equipment and phantoms .
material Dimensions thickness purity
Standard 45 PMMA At all sides > 5mm 45±0.5 mm

mm thick larger than X-ray beam
PMMA block
slabs PMMA ≥ 240mm x 180 mm 10±0.1mm
Z-resolution PMMA with 25 PMMA: 240.mm x PMMA: 5±0.1
phantom Aluminium 300.mm mm
spheres Aluminium
spheres: 1.00±
0.03 mm
NPS attenuator Aluminium Covering the whole X- 2±.. mm 99%
ray beam
MTF phantom Stainless steel 50±.. mm x 50±.. mm 1±.. mm
Tungsten wire Tungsten 25±.. µm
diameter
SDNR sheet aluminium 10±1 mm x 10±1. mm 0.200±0.002 mm 99%
Protective plate e.g. Stainless covering the whole e.g. 3 ± 1 mm
steel image receptor stainless steel
Self developing Sensitive for
film mammography
X-ray spectra
Focal spot size
phantom
CDMAM
phantom
Block of foam Density:.. 240mm x 180mm
X-ray rulers
TableIV.2 Specifications of meters.
Accuracy Reproducibility
Exposure time meter 5% 1%
Dose meter 5% 1%
Tube voltage meter 5% 1%
Compression force meter 10% 5%
67
Appendix V List of definitions (provisional)
AEC Automatic Exposure Control

AGD Average Glandular Dose
Angular range The difference between the first and last projection angle of a
tomosynthesis acquisition.
Bad pixel map A map (either an image or a table) which defines the position of all pixels
for which the pixel value is not based on its own del reading (in 2D
mammography or projection images in 3D mammography).
Bit-depth Number of values which can be assigned to a single pixel in a specific
digital system, expressed in bits.
Centre of rotation Centre point of the rotational movement of a tomosynthesis system.
DBT Digital breast tomosynthesis
Del Single discrete detector element in a DR detector.
Detector corrections Corrections in DR systems in which the values of defective detector
elements/columns/rows are reconstructed and the values are corrected for
variations in individual detector element sensitivity and electronic gain.
Ghost image Residuals from previous images on the current image.
Exposure time The total time between the start and end of the exposure of an individual
point of an object in a tomosynthesis sequence.
FFDM Full Field Digital Mammography, 2D mammography
Focal spot line Line from the focal spot to the centre of the image receptor
Focal plane Part of the object that is in focus in a reconstructed tomosynthesis image.
Full-field geometry Geometry of DBT systems incorporating a detector as used in
conventional 2D full field digital mammography (FFDM), and an X-ray
tube that rotates above this detector. A series of individual projection
images, in which the whole breast is irradiated in each exposure, are
acquired over a range of angles.
Linearised pixel value In FFDM or tomosynthesis projection images there may not be a
directly proportional relationship between pixel value and dose to the
detector. In this case, if pixel values are to be used to represent dose (for
example in calculating SDNR), it is necessary to “linearise” the pixel
values by applying a correction. In many cases this correction will be as
simple as subtracting a pixel offset from the raw pixel value.
68
Noise Fluctuations in pixel values which are unrelated to the imaged object. The
standard deviation in a ROI in the output image is taken as measure of
noise.
Pixel Picture element, the smallest unit in an electronic image.
Pixel pitch Physical distance between the centres of adjacent pixels. In DICOM tags
pixel pitch is called imager pixel spacing and is generally equal to detector
element spacing.
Pixel value Discrete value assigned to a pixel. In mammography systems the number
of pixel values range from 1024 (10-bits) to 16384 (14 bits), depending on
the system.
Pixel value offset Fixed value that is added to the values of all pixels.
PMMA Polymethyl methacrylate
Projection angle The angle between the focal spot line and the zero degree line on a
tomosynthesis system.
Projection image An image made with a certain projection angle. A series of projection
images are made in DBT imaging using a Full-field detector.
Processed image The image after image processing, ready for presentation on the monitor
or print-out. In the DICOM file the value of the element Presentation
Intent Type (0008,0068) is ‘for presentation’.
Processed projection image A projection image after processing. A manufacture might process
the projection images before image reconstruction.
Raw image See unprocessed image
Reconstructed plane Part of the volume that is reconstructed
Reconstructed volume A representation of the imaged object consisting of a series of focal
planes.
Reference region-of-interest A region-of-interest (size:5 x 5 mm) in the plane at 20 mm
height above the bucky table in the reconstructed tomosynthesis image.
The centre of the region-of-interest is positioned 60 mm perpendicular to
the chest wall edge of the table and centred laterally.
Reference value For some test-items limiting values are not given. However some guidance
is given by the use of reference values, mostly derived from the limiting
values in FFDM. These limiting values have been chosen as reference
values because the benefit of DBT in e.g. terms of cancer detection, versus
the cost in terms of radiation dose is not yet clear. Applying too many
restrictions in this early stage in the development of DBT may lead to a
suboptimal dose-image quality balance. However, exceeding the limiting
values of FFDM should only be accepted if clear benefit for the
patient/client is expected.
69
Rotation angle Angle between the line from focal spot to the centre of rotation and the
zero degree line.
Scan Complete cycle of a tomosynthesis acquisition
Scan Time The time between the start of the first exposure and the end of the last
exposure of a tomosynthesis sequence.
Scanning geometry Geometry of DBT systems utilising a narrow collimated X-ray beam
which scans across the breast as the X-ray tube rotates, and by which the
breast is only partially irradiated at each position of the X-ray tube. Due to
the design of the system and continuous readout from the detector,
individual projection images might not exist.
SDNR Signal Difference to Noise Ratio
SNR Signal to Noise Ratio: In FFDM imaging SNR is calculated as follows for
a specific ROI:
mean pixel value - pixel value offset
SNR 
standard deviation in pixel value
Standard test block PMMA test object (thickness 45±0.5 mm, length and width at least 5 mm
larger than the detector area) to represent approximately the average
breast. The block may consist of several thinner slabs.
Straight through position The position of the focal spot in which the focal spot line equals the
zero degree line.
Threshold contrast The smallest contrast of a given object size that can be visualized by a
human observer using the evaluated system. The threshold contrast is a
measure for imaging of low-contrast structures.
Unprocessed image The image of a DR system after flat-fielding and detector corrections but
before other image processing has been applied. In the unprocessed image
the pixel value is in general linear with pixel exposure. In the DICOM
header the value of the element Presentation Intent Type (0008,0068)is
‘for processing’. Sometimes unprocessed images are referred as ‘raw data’
Unprocessed projection image See projection image.
min  max
Variation x 100%
mean
Z-direction On DBT systems, the z-direction is the direction perpendicular to the
breast support table.
Zero degree projection A projection in which a line through the focal spot and centre of
rotation is perpendicular to the bucky surface.
Zero degree angle stationary mode A stationary mode at zero degree angle in which the
exposures of all projection images is given without movement of the X-
70
ray tube. In this mode it must be possible to choose similar X-ray spectra
as in standard DBT mode.
Zero degree line A line from the focal spot towards the centre of rotation so that the focal
spot line is perpendicular to the bucky surface.
71

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Protocol

for the Quality Control of the

Draft version 0.15

European Reference Organisation for Quality Assured Breast

* Members of Physico-technical Steering Group

1 X-ray generation .............................................................................................................................................. 12

1.2 Focal spot motion (optional) ........................................................................................................................ 12

1.4 Tube output ................................................................................................................................................... 14

1.5 Tube voltage and beam quality ..................................................................................................................... 15

1.5.1 Tube voltage ........................................................................................................................................ 15

1.5.2 Half Value Layer (HVL) ..................................................................................................................... 15

1.6 Exposure distribution per projection image (optional) ................................................................................ 16

2.2 Short term reproducibility ............................................................................................................................ 17

2.3 Long term reproducibility ............................................................................................................................. 18

2.4 AEC performance ......................................................................................................................................... 18

4 Image receptor ................................................................................................................................................. 23

4.1.1 Response function ............................................................................................................................... 23

4.1.2 Noise analysis...................................................................................................................................... 23

4.2 Detector element failure ............................................................................................................................... 25

4.3 Uncorrected defective detector elements ...................................................................................................... 25

4.4 System projection MTF (optional) ................................................................................................................ 25

5 Image quality of the reconstructed image ..................................................................................................... 27

5.2 Z-resolution .................................................................................................................................................. 28

5.3 MTF in the x-y plane (optional) ................................................................................................................... 31

5.4 Noise Power Spectra (optional) .................................................................................................................... 33

5.6 Homogeneity of the reconstructed tomosynthesis image .............................................................................. 34

5.7 Geometric distortion ..................................................................................................................................... 34

6 Dosimetry for digital breast tomosynthesis ................................................................................................... 37

6.1.1 Full field geometry .............................................................................................................................. 37

6.1.2 Scanning geometry .............................................................................................................................. 38

6.2 Assessing Average Glandular Dose .............................................................................................................. 39

6.2.2 Assessing clinical breast doses ............................................................................................................ 42

7 Image presentation .......................................................................................................................................... 44

7.1.1 Ambient light ...................................................................................................................................... 44

7.1.2 Geometrical distortion (CRT displays) ............................................................................................... 44

7.1.3 Contrast visibility ................................................................................................................................ 45

7.1.4 Resolution ........................................................................................................................................... 47

7.1.5 Display artefacts .................................................................................................................................. 47

7.1.6 Luminance range ................................................................................................................................. 48

7.1.7 Greyscale Display Function ................................................................................................................ 48

7.1.8 Luminance uniformity ......................................................................................................................... 49

Appendix I. Tables for dosimetry calculation in digital breast tomosynthesis ............................................. 56

Appendix II Noise Power Spectrum (NPS) ...................................................................................................... 65

Appendix II.2 NPS in the reconstructed tomosynthesis image ............................................................................... 65

Appendix IV Specifications and tolerances of equipment and phantoms ............................................................ 67

Appendix V List of definitions (provisional) review by group. Nick ............................................................. 68

Two types of DBT geometries are currently available or under development:

Number of projection 9 15 13 213 15 25 15

Aim of this draft version:

1.2 Focal spot motion (optional)

Limiting values: For reference purposes

Bucky Light field

Frequency: At acceptance and every six months

1.4 Tube output

1.5 Tube voltage and beam quality

1.5.1 Tube voltage

1.5.2 Half Value Layer (HVL)

1.6 Exposure distribution per projection image (optional)

2.1 Back-up timer/security cut-off