GE SenographePristinaTechnical 2D 2019
GE SenographePristinaTechnical 2D 2019
GE SenographePristinaTechnical 2D 2019
Equipment Report
Technical evaluation of GE Senographe
Pristina digital mammography system in
2D mode
December 2019
Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Contents
About Public Health England
About PHE Screening
Executive summary 4
1. Introduction 5
1.1 Testing procedures and performance standards for digital mammography 5
1.2 Objectives 5
2. Methods 5
2.1 System tested 5
2.2 Output and HVL 6
2.3 Detector response 7
2.4 Dose measurement 7
2.5 Contrast-to-noise ratio 8
2.6 AEC performance for local dense areas 10
2.7 Noise analysis 11
2.8 Image quality measurements 12
2.9 Physical measurements of the detector performance 13
2.10 Other tests 14
3. Results 14
3.1 Output and HVL 14
3.2 Detector response 14
3.3 AEC performance 16
3.4 Noise measurements 21
3.5 Image quality measurements 23
3.6 Comparison with other systems 25
3.7 Detector performance 29
3.9 Other tests 31
4. Discussion 34
5. Conclusions 35
References 36
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Executive summary
The purpose of the evaluation was to determine whether the GE Senographe Pristina
meets the main standards in the NHS Breast Screening Programme (NHSBSP) and
European protocols, and to provide performance data for comparison against other
systems.
The mean glandular dose (MGD) was found to be well below the remedial level for all
automatic exposure control (AEC) modes. For the 53mm equivalent standard breast,
the MGD was 1.19mGy in Standard mode, compared with the remedial level of 2.5mGy.
The image quality, as measured by threshold gold thickness, is at the achievable level
for the Standard mode.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
1. Introduction
1.1 Testing procedures and performance standards for digital mammography
This report is one of a series evaluating commercially available direct digital radiography
(DR) systems for mammography on behalf of the NHS Breast Screening Programme
(NHSBSP). The testing methods and standards applied are mainly derived from
NHSBSP Equipment Report 06041 which is referred to in this document as ‘the
NHSBSP protocol’. The standards for image quality and dose are the same as those
provided in the European protocol,2,3 but the latter has been followed where it provides
a more detailed standard, for example, for the automatic exposure control (AEC)
system.
Some additional tests were carried out according to the UK recommendations for testing
mammography X-ray equipment as described in IPEM Report 89.4
1.2 Objectives
2. Methods
2.1 System tested
The tests were conducted at the GE factory in Buc, Paris, on a GE Senographe Pristina
system as described in Table 1. The Pristina is shown in Figure 1.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Four AEC modes are available for use with the Pristina, as listed in table 1. The AEC is
referred to by GE as Automatic Optimisation of Parameters (AOP).
Exposure factors 26kV Mo/Mo are used for small breasts, for exposures at up to 35mm
radiological thickness, which is defined as the equivalent thickness of polymethyl
methacrylate (PMMA) plus 2mm or 5%. For thicker breasts the factors used are 34kV
Rh/Ag. The mAs is selected as appropriate for the most dense part of the breast. 29kV
Mo/Mo is used for exposures of smaller thicknesses when the magnification table is in
use.
An ion chamber was used to measure the output and half-value-layer (HVL), as
described in the NHSBSP protocol, at intervals of 3kV. Tube voltage was measured with
a RMI 232 kV meter, which was only calibrated for Mo/Mo exposures.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
The detector response was measured as described in the NHSBSP protocol, except
that 2mm thick aluminium was used at the tubehead, instead of PMMA. The grid was
removed and an ion chamber was positioned above the detector cover, 40mm from the
chest wall edge (CWE). The incident air kerma was measured for a range of manually
set mAs values at 34kV Rh/Ag. The readings were corrected to the surface of the
detector using the inverse square law. No correction was made for attenuation by the
detector cover. A 10mm x 10 mm region of interest (ROI) was positioned on the midline,
40mm from the CWE of each image. The average pixel value and the standard
deviation of pixel values within the ROI were measured. The relationship between
average pixel values and the air kerma incident at the detector was determined.
Doses were measured using the AEC in the different modes to expose different
thicknesses of PMMA. Each PMMA block had an area of 180mm x 240mm. Spacers
were used to adjust the paddle height to be equal to the equivalent breast thickness, as
shown in Table 3. The exposure factors were noted and mean glandular doses (MGDs)
were calculated for equivalent breast thicknesses. The value of s used in the calculation
of MGD for the Rh/Ag target filter combination was 1.087.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
An aluminium square, 10mm x 10mm and 0.2mm thick, was used with the PMMA
blocks during these exposures, so that the images produced could be used for the
calculation of the contrast-to-noise ratio (CNR), described in Section 2.5. The aluminium
square was placed between two 10mm thick slabs of 180mm x 240mm PMMA, on the
midline, with its centre 60mm from the CWE. Additional layers of PMMA were placed on
top to vary the total thickness.
Unprocessed images acquired during the dose measurement were analysed to obtain
the CNRs. Thirty six small square ROIs (approximately 2.5mm x 2.5mm) were used to
determine the average signal and the standard deviation in the signal within the image
of the aluminium square (4 ROIs) and the surrounding background (32 ROIs), as shown
in Figure 2. Small ROIs are used to minimise distortions due to the heel effect and other
causes of non-uniformity.5 The CNR was calculated for each image, as defined in the
NHSBSP and European protocols.
To apply the standards in the European protocol, it is necessary to relate the image
quality measured using the CDMAM (Section 2.8) for an equivalent breast thickness of
60mm, to that for other breast thicknesses. The European protocol2 gives the
relationship between threshold contrast and CNR measurements, enabling the
calculation of a target CNR value for a particular level of image quality. This can be
compared to CNR measurements made at other breast thicknesses. Contrast for a
particular gold thickness is calculated using Equation 1, and target CNR is calculated
using Equation 2.
where µ is the effective attenuation coefficient for gold, and t is the gold thickness.
CNRmeasured × TCmeasured
CNR target = (2)
TCtarget
where CNRmeasured is the CNR for a 60mm equivalent breast, TCmeasured is the threshold
contrast calculated using the threshold gold thickness for a 0.1mm diameter detail,
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
(measured using the CDMAM at the same dose as used for CNRmeasured), and TCtarget
is the calculated threshold contrast corresponding to the threshold gold thickness
required to meet either the minimum acceptable or achievable level of image quality as
defined in the UK standard.
The threshold gold thickness for the 0.1mm detail diameter is used here because it is
generally regarded as the most critical of the detail diameters for which performance
standards are set.
The effective attenuation coefficient for gold used in Equation 1 depends on the beam
quality used for the exposure, and was selected from a table of values summarised in
Table 2. These values were calculated with 3mm PMMA representing the compression
paddle, using spectra from Boone et al.6 and attenuation coefficients for materials in the
test objects (aluminium, gold, PMMA) from Berger et al.7
The European protocol also defines a limiting value for CNR, which is calculated as a
percentage of the threshold contrast for minimum acceptable image quality for each
thickness. This limiting value varies with thickness, as shown in Table 3.
Table 2. Effective attenuation coefficients for gold contrast details in the CDMAM
kV Target/filter Effective attenuation coefficient
(μm-1)
34 Rh/Ag 0.110
The target CNR values for minimum acceptable and achievable levels of image quality
and European limiting values for CNR were calculated. These were compared with the
measured CNR results for all breast thicknesses.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
This test is described in the supplement to the fourth edition of the European protocol.3
To simulate local dense areas, images of a 30mm thick block of PMMA of size 180mm x
240mm, were acquired under AEC. Extra PMMA between 2 and 20mm thick and of size
20mm x 40mm was added to provide extra attenuation. The compression plate
remained in position at a height of 40mm, as shown in Figure 3. The simulated dense
area was positioned 50mm from the CWE of the table.
In the simulated local dense area the mean pixel value and standard deviation for a
10mm x 10mm ROI were measured and the signal-to-noise ratios (SNRs) were
calculated.
Guidance for this test suggests that the SNR for each image should be within 20% of
the mean SNR.
Top view
Extra attenuation
Side view
Compression paddle
40mm
30mm
Bucky
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
The images acquired in the measurements of detector response, using 34kV Rh/Ag,
were used to analyse the image noise. Small ROIs with an area of approximately
2.5mm x 2.5mm were placed on the midline, 60mm from the CWE. The average
standard deviations of the pixel values in these ROIs for each image were used to
investigate the relationship between the dose to the detector and the image noise. It
was assumed that this noise comprises three components: electronic noise, structural
noise, and quantum noise. The relationship between them is shown in Equation 3.
where σp is the standard deviation in pixel values within an ROI with a uniform exposure
and a mean pixel value p, and ke, kq, and ks are the coefficients determining the amount
of electronic, quantum, and structural noise in a pixel with a value p. This method of
analysis has been described previously.8 For simplicity, the noise is generally presented
here as relative noise defined as in Equation 4.
σp
Relative noise = (4)
p
The variation in relative noise with mean pixel value was evaluated and fitted using
Equation 3, and non-linear regression used to determine the best fit for the constants
and their asymptotic confidence limits (using Graphpad Prism version 6.05 for Windows,
Graphpad software, San Diego, California, USA, www.graphpad.com). This established
whether the experimental measurements of the noise fitted this equation, and the
relative proportions of the different noise components. The relationship between noise
and pixel values has been found empirically to be approximated by a simple power
relationship as shown in Equation 5.
σp
= ktp-n (5)
p
where kt is a constant. If the noise were purely quantum noise the value of n would be
0.5. However the presence of electronic and structural noise means that n can be
slightly higher or lower than 0.5.
The variance in pixel values within a ROI is defined as the standard deviation squared.
The total variance was plotted against incident air kerma at the detector and fitted using
Equation 3. Non-linear regression was used to determine the best fit for the constants
and their asymptotic confidence limits, using the Graphpad Prism software.
Using the calculated constants, the structural, electronic, and quantum components of
the variance were estimated, assuming that each component was independently related
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
to incident air kerma. The percentage of the total variance represented by each
component was then calculated and plotted against incident air kerma at the detector.
Contrast detail measurements were made using a CDMAM phantom (serial number
1022, version 3.4, UMC St. Radboud, Nijmegen University, Netherlands). The phantom
was positioned with a 20mm thickness of PMMA above and below, to give a total
attenuation approximately equivalent to 50mm of PMMA or 60mm thickness of typical
breast tissue. The exposure factors were chosen to be close to those selected by the
AEC, in Standard mode, when imaging a 50mm thickness of PMMA. This procedure
was repeated to obtain a representative sample of 16 images at this dose level. Further
sets of 16 images of the test phantom were then obtained at other dose levels by
manually selecting higher and lower mAs values with the same beam quality.
The CDMAM images were read and analysed automatically using Version 1.6 of
CDCOM9,10 and Version 2.1.0 of CDMAM Analysis (available on request from
www.nccpm.org). The threshold gold thickness for a typical human observer was
predicted using Equation 6.
where TCpredicted is the predicted threshold contrast for a typical observer, TCauto is the
threshold contrast measured using an automated procedure with CDMAM images. r is
the average ratio between human and automatic threshold contrast determined
experimentally with the values shown in Table 4.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
The predicted threshold gold thickness for each detail diameter in the range 0.1mm to
1.0mm was fitted with a curve for each dose level, using the relationship shown in
Equation 7.
where x is the detail diameter, and a, b, c and d are coefficients adjusted to obtain a
least squares fit.
The confidence limits for the predicted threshold gold thicknesses have been previously
determined by a sampling method using a large set of images. The threshold contrasts
quoted in the tables of results are derived from the fitted curves, as this has been found
to improve accuracy.
The expected relationship between threshold contrast and dose is shown in Equation 8.
where D is the MGD for a 60mm thick standard breast (equivalent to the test phantom
configuration used for the image quality measurement), and λ is a constant to be fitted.
It is assumed that a similar equation applies when using threshold gold thickness
instead of contrast. This equation was plotted with the experimental data for detail
diameters of 0.1 and 0.25mm. The value of n resulting in the best fit to the experimental
data was determined, and the doses required for target CNR values were calculated for
data relating to these detail diameters.
The presampled modulation transfer function (MTF), normalised noise power spectrum
(NNPS) and the detective quantum efficiency (DQE) of the system were measured. The
methods used were as close as possible to those described by the International
Electrotechnical Commission (IEC).11 The radiation quality used for the measurements
was adjusted by placing a uniform 2mm thick aluminium filter at the tube housing. The
beam quality used was 26kV Mo/Mo. The test device to measure the MTF comprised a
120mm x 60mm rectangle of stainless steel with polished straight edges, of thickness
0.8mm. The grid was removed by sliding the complete bucky out and then the MTF test
device was placed on the detector entrance cover. The test device was positioned to
measure the MTF in two directions, first almost perpendicular to the CWE and then
almost parallel to it. A 10th order polynomial fit was applied to the results.
To measure the noise power spectrum the test device was removed and exposures
made for a range of incident air kerma at the surface of the table. The DQE is presented
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Other tests were carried out to cover the range that would normally form part of a
commissioning survey on new equipment. These included tests prescribed in IPEM
Report 894 for mammographic X-ray sets, as well as those in the UK NHSBSP protocol
for digital mammographic systems
3. Results
3.1 Output and HVL
The tube voltage measurements are shown in Table 6. All were within 0.3kV of
indicated values and are within the IPEM Report 894 remedial level of ±1kV.
kV set kV measured
26 25.8
28 27.9
30 30.2
32 32.3
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
6000
A v e ra g e p ix e l v a lu e
4000
y = 9 .8 x
2000
0
0 200 400 600
In c id e n t a ir k e r m a a t d e te c to r ( µ G y )
Figure 4. Detector response acquired at 34kV Rh/Ag anode/filter combination with 2mm
Al at the tube port
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
3.3.1 Dose
The MGDs for breasts simulated with PMMA, exposed using the 4 different AEC modes, are
shown in Figure 5 and Tables 7 to 10. The MGDs include the pre-pulse exposure, which is not
included in the stated mAs values.
8
Standard
Dose-
Standard+
6 Implant
MGD (mGy)
0
0 20 40 60 80 100
Equivalent breast thickness (mm)
Figure 5 MGD for different thicknesses of simulated breasts in the 4 AEC modes. (Error
bars indicate 95% confidence limits.)
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
The results of the CNR measurements are shown in Figure 6 and Tables 11 to 12. The
following calculated values are also shown:
• CNR to meet the minimum acceptable image quality (IQ) standard at the 60mm
breast thickness
• CNR to meet the achievable image quality standard at the 60mm breast thickness
• CNRs at each thickness to meet the limiting value in the European protocol
S ta n d a rd
40 D ose-
S ta n d a rd +
Im p la n t
C N R fo r 0 .2 m m A l
C N R a t m in im u m IQ
30
C N R a t a c h ie v a b le IQ
C N R to m e e t E u ro p e a n lim itin g v a lu e
20
10
0
0 20 40 60 80 100
E q u iv a le n t b r e a s t th ic k n e s s ( m m )
Figure 6. CNR measured at the 4 AEC modes. (Error bars indicate 95% confidence
limits.)
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
For many systems, when the AEC adjusts for locally dense areas, the SNR remains
constant with increasing thickness of extra PMMA. The results of this test are shown in
Tables 13 to16 and Figure 7. The need for a more suitable test for the Pristina, for
which the aim is to keep CNR (rather than SNR) constant, is discussed in section 4.
For Standard, Dose- and Standard+ modes, the first 2 exposures are at 26kV Mo/Mo.
For greater thicknesses the exposures are at 34kV Rh/Ag and the SNR jumps to a
higher value, and then decreases only slowly with increasing thickness of PMMA. In
Implant mode, all exposures are at 34kV Rh/Ag, and the SNR decreases slowly from
the initial value.
Most SNR values are within the suggested limit of 20% of the mean SNR. Only for the
Mo/Mo exposures. The implant mode is designed to give exposures dependent on the
breast thickness, therefore this test is not relevant.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Table 13. AEC performance for local dense areas, AEC Standard mode
Total kV Target/ Tube SNR % difference
attenuation filter load from average
(mm PMMA) (mAs)
32 26 Mo/Mo 45.7 98.1 -20
34 26 Mo/Mo 54.2 97.1 -21
36 34 Rh/Ag 20.7 140.8 15
38 34 Rh/Ag 22.2 139.1 14
40 34 Rh/Ag 23.7 135.2 10
42 34 Rh/Ag 24.7 128.3 5
44 34 Rh/Ag 26.6 126.5 3
46 34 Rh/Ag 27.6 123.1 0
48 34 Rh/Ag 30.0 120.0 -2
50 34 Rh/Ag 31.8 117.2 -4
Table 14. AEC performance for local dense areas, AEC Dose- mode
Total kV Target/ Tube SNR % difference
attenuation filter load from average
(mm PMMA) (mAs)
32 26 Mo/Mo 32.0 79.4 -24
34 26 Mo/Mo 37.7 80.3 -23
36 34 Rh/Ag 15.0 117.6 13
38 34 Rh/Ag 16.0 114.9 10
40 34 Rh/Ag 17.6 114.4 10
42 34 Rh/Ag 18.6 111.4 7
44 34 Rh/Ag 20.3 111.4 7
46 34 Rh/Ag 21.2 106.6 2
48 34 Rh/Ag 23.0 102.3 -2
Table 15. AEC performance for local dense areas, AEC Standard+ mode
Total kV Target/ Tube SNR % difference
attenuation filter load from average
(mm PMMA) (mAs)
32 26 Mo/Mo 49.6 102.0 -27
34 26 Mo/Mo 59.9 101.8 -27
36 34 Rh/Ag 24.4 152.5 9
38 34 Rh/Ag 26.5 153.7 10
40 34 Rh/Ag 30.1 149.1 7
42 34 Rh/Ag 32.8 150.1 7
44 34 Rh/Ag 37.0 149.2 7
46 34 Rh/Ag 40.1 148.3 6
48 34 Rh/Ag 45.4 143.5 3
50 34 Rh/Ag 49.4 149.6 7
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Table 16. AEC performance for local dense areas, AEC Implant mode
Total kV Target/ Tube SNR % difference
attenuation filter load from average
(mm PMMA) (mAs)
32 34 Rh/Ag 25.2 174.8 27
34 34 Rh/Ag 26.5 169.4 23
36 34 Rh/Ag 26.5 158.6 15
38 34 Rh/Ag 25.2 147.6 7
40 34 Rh/Ag 25.2 136.0 -1
42 34 Rh/Ag 26.5 134.3 -2
44 34 Rh/Ag 25.2 120.8 -12
46 34 Rh/Ag 26.5 120.1 -13
48 34 Rh/Ag 25.2 109.9 -20
50 34 Rh/Ag 25.2 103.5 -25
S ta n d a rd
200 D ose-
S ta n d a rd +
Im p la n t
150
SNR
100
50
0
30 35 40 45 50 55
P M M A th ic k n e s s ( m m )
The variation in noise with dose was analysed by plotting the standard deviation in pixel
values against the incident air kerma at the detector, as shown in Figure 8. The fitted
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
power curve has an index of 0.54, which is close to the expected value of 0.5 for
quantum noise sources alone.
100
S ta n d a r d d e v ia tio n in p ix e l v a lu e
0 .5 4
y = 0 .6 1 x
10
1
100 1000
In c id e n t a ir k e r m a a t s u r fa c e o f d e te c to r ( µ G y )
Figure 8. Standard deviation of pixel values versus incident air kerma at detector
0 .0 1 5
M e a s u re d n o is e
F it to d a ta
Q u a n tu m n o is e
R e la tiv e n o is e
E le c tr o n ic n o is e
0 .0 1 0
S tru c tu ra l n o is e
0 .0 0 5
0 .0 0 0
0 200 400 600
In c id e n t a ir k e r m a a t s u r fa c e o f d e te c to r ( µ G y )
Figure 9 shows the relative noise at different incident air kerma. The estimated relative
contributions of electronic, structural, and quantum noise are shown and the quadratic
sum of these contributions fitted to the measured noise (using Equation 3).
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Figure 10 shows the different amounts of variance due to each component; the
quantum variance is seen to predominate.
S tru c tu ra l v a r ia n c e
Q u a n tu m v a ria n c e
E le c tro n ic v a r ia n c e
100
% o f to ta l v a ria n c e
50
0
50 100 500 1000
In c id e n t a ir k e r m a a t s u r fa c e o f d e te c to r ( µ G y )
Figure 10. Noise components as a percentage of the total variance. (Error bars indicate
95% confidence limits.)
The exposure factors used for each set of 16 CDMAM images are shown in Table 17.
The contrast detail curves (determined by automatic reading of the images) at the
different dose levels are shown in Figure 11. The threshold gold thicknesses measured
for different detail diameters at the 5 selected dose levels are shown in Table 18. The
NHSBSP minimum acceptable and achievable limits are also shown.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
The measured threshold gold thicknesses are plotted against the MGD for an equivalent
breast for the 0.1mm and 0.25mm detail sizes in Figure 12.
M G D = 0 .6 0 m G y
10 M G D = 0 .8 3 m G y
T h r e s h o ld g o ld th ic k n e s s ( µ m )
M G D = 1 .2 1 m G y
M G D = 1 .7 0 m G y
M G D = 2 .3 7 m G y
1 A c c e p ta b le
A c h ie v a b le
0 .1
0 .1 0 0 .1 3 0 .1 6 0 .2 0 0 .2 5 0 .3 1 0 .4 0 0 .5 0 0 .6 3 0 .8 0 1 .0 0
D ia m e te r ( m m )
Figure 11. Contrast-detail curves for 5 doses at 34kV Rh/Ag. (Error bars indicate 95%
confidence limits.)
Table 18. Average threshold gold thicknesses for different detail diameters for 5 doses
using 34kV Rh/Ag, and automatically predicted data
Threshold gold thickness (μm)
Diam
Accept Achiev
-eter
-able -able MGD = MGD = MGD = MGD = MGD =
(mm)
value value 0.60mGy 0.83mGy 1.21mGy 1.70mGy 2.37mGy
0.1 1.680 1.100 2.21 ± 0.22 1.30 ± 0.13 1.16 ± 0.11 1.00 ± 0.01 0.70 ± 0.07
0.25 0.352 0.244 0.371± 0.037 0.285 ± 0.029 0.260± 0.026 0.204 ± 0.020 0.188 ± 0.019
0.5 0.150 0.103 0.160 ± 0.019 0.31± 0.02 0.099 ± 0.012 0.085 ± 0.010 0.074 ± 0.009
1.0 0.091 0.056 0.074 ± 0.015 0.059± 0.012 0.048 ± 0.010 0.039 ± 0.008 0.031 ± 0.006
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
2 0.4 minimum
minimum
achievable
achievable
1 0.2
0 0.0
0 1 2 3 4 0 1 2 3 4
Dose (mGy) Dose (mGy)
Figure 12. Threshold gold thickness at different doses. (Error bars indicate 95%
confidence limits.)
The MGDs to reach the minimum and achievable image quality standards in the
NHSBSP protocol have been estimated from the curves shown in Figure 12. The fitted
curves are of the form y = x-n. (The error in estimating these doses depends on the
accuracy of the curve fitting procedure, and pooled data for several systems has been
used to estimate the 95% confidence limits of about 20%.) These doses are shown
against similar data for different models of digital mammography systems in Tables 19
and 20 and Figures 13 to 16. The data for these systems has been determined in the
same way as described in this report and the results published previously.12-18 The data
for film-screen represents an average value determined using a variety of film-screen
systems in use prior to their discontinuation.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Table 19. The MGD for a 60mm equivalent breast for different systems to reach the
minimum acceptable threshold gold thickness for 0.1mm and 0.25mm details
System MGD (mGy) for 0.1mm MGD (mGy) for 0.25mm
Table 20. The MGD for a 60mm equivalent breast for different systems to reach the
achievable threshold gold thickness for 0.1mm and 0.25mm details
System MGD (mGy) for 0.1mm MGD (mGy) for 0.25mm
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
remedial dose level
3
MGD (mGy)
0
ss
s
l
en
y
a
n
ia
on
rit
lit
12
tin
io
la
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at
si
is
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im
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s
an
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en
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Pl
D
i
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og
ro
ic
ol
Si
M
H
s
ilip
Ph
Figure 13. MGD for a 60mm equivalent breast to reach minimum acceptable image
quality standard for 0.1mm detail. (Error bars indicate 95% confidence limits.)
remedial dose level
3
MGD (mGy)
0
ss
s
l
en
y
a
n
ia
on
rit
lit
12
tin
io
la
nt
re
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la
at
si
is
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C
se
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tto
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R
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G
Fi
3D
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e
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s
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D
i
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H
s
ilip
Ph
Figure 14. MGD for a 60mm equivalent breast to reach achievable image quality standard
for 0.1mm detail. (Error bars indicate 95% confidence limits.)
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
remedial dose level
3
MGD (mGy)
0
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M
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ilip
Ph
Figure 15. MGD for a 60mm equivalent breast to reach minimum acceptable image
quality standard for 0.25mm detail. (Error bars indicate 95% confidence limits.)
remedial dose level
3
MGD (mGy)
0
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Figure 16. MGD for a 60mm equivalent breast to reach achievable image quality standard
for 0.25mm detail. (Error bars indicate 95% confidence limits.)
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
The MTF is shown in Figure 17 for the two orthogonal directions. Figure 18 shows the
NNPS curves for a range of air kerma incident to the detector.
1 .0
M T F (v ) p e r p e n d ic u la r to tu b e a x is
M T F (u ) p a ra lle l to tu b e a x is
0 .8
0 .6
M TF
0 .4
0 .2
0 .0
0 2 4 6 8 10
-1
S p a tia l fr e q u e n c y ( m m )
1 6 .3 µ G y N P S ( u ) 6 6 .2 µ G y N P S ( v )
1 6 .3 µ G y N P S ( v ) 1 3 4 µ G y N P S (u )
-4
10
3 2 .8 µ G y N P S ( u ) 1 3 4 µ G y N P S (v )
3 2 .8 µ G y N P S ( v ) 2 6 7 µ G y N P S (u )
6 6 .2 µ G y N P S ( u ) 2 6 7 µ G y N P S (v )
-5
10
N N P S (m m )
2
-6
10
-7
10
0 2 4 6
-1
S p a tia l fr e q u e n c y ( m m )
Figure 18. NNPS curves for a range of air kerma incident to the detector
29
Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Figure 19 shows the DQE averaged in the two orthogonal directions for a range of
entrance air kerma. The MTF and DQE measurements were interpolated to show
values at standard frequencies in Table 21.
0 .8 1 6 .3 µ G y
3 2 .8 µ G y
6 6 .2 µ G y
0 .6
134 µG y
267 µG y
DQE
0 .4
0 .2
0 .0
0 1 2 3 4 5 6
-1
S p a tia l fr e q u e n c y ( m m )
Figure 19. DQE averaged in both directions for a range of air kerma incident to the
detector
Table 21. MTF and DQE measurements at standard frequencies (DQE at 66.2µGy)
Frequency (mm-1) MTF (u) MTF (v) DQE
0.0 1.00 1.00 -
0.5 0.92 0.92 0.68
1.0 0.85 0.86 0.68
1.5 0.76 0.77 0.65
2.0 0.65 0.67 0.63
2.5 0.55 0.57 0.59
3.0 0.46 0.49 0.55
3.5 0.38 0.41 0.50
4.0 0.31 0.35 0.42
4.5 0.25 0.29 0.33
5.0 0.20 0.23 0.24
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
The results of all the other tests that were carried out were within acceptable limits as
prescribed in the UK protocol1 and IPEM Report 89.4
3.9.1 Compression
The measured compressed breast thicknesses are compared with the displayed values
in Table 22. They were within 2mm of displayed values. This is well within the IPEM
Report 894 remedial level of > 5mm.
Measurements of compression force together with the IPEM Report 894 remedial levels
are shown in Table 23.
The image retention factor was 0.01, compared to the NHSBSP upper limit of 0.3.
The missed tissue was measured as 5mm, which is equal to the NHSBSP limit.
3.9.4 Mesh
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
3.9.5 Distortion
Measurements showed that there was no distortion in an image of small aluminium balls
spaced 50mm apart across the whole image (the tomosynthesis test tool).
For a series of 5 repeat images, acquired in quick succession, the maximum deviation
of mAs from the mean was 1.3%. For 6 images, acquired at intervals over several days
of testing, the maximum deviation was 1.9%. The NHSBSP remedial level is 5%.
There was slight visible non-uniformity in the unprocessed image, as shown in Figure
20. A plot of mean pixel value along the midline, from CWE to nipple edge, is shown in
Figure 21.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
1000
800
M e a n p ix e l v a lu e
600
400
200
0
0 50 100 150 200 250
D is ta n c e fr o m C W E ( m m )
For a typical exposure of 34kV Rh/Ag at 28mAs, a subsequent exposure could be made
17 seconds after the start of the previous one.
When an AEC exposure was attempted with a steel plate blocking the X-ray beam, the
exposure terminated after a short time of less than 1s after the pre-exposure. There was
no main exposure and no image acquired. A message “AOP aborted, change
acquisition mode” was displayed.
All movements were smooth. The minimum height of the breast support table was 65cm
and the maximum was 150cm. There were no rough edges.
The safety cut-out (red button) on the console stopped operation when pressed. The
display remained on and the system could be rebooted from the console.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
4. Discussion
The detector response was found to be linear, as expected.
MGDs measured using PMMA were well within the NHSBSP limits for all equivalent
breast thicknesses in all 4 AEC modes (Figure 5). The MGDs to a 53mm equivalent
breast thickness were 1.19mGy, 0.93mGy, 1.70mGy and 1.70mGy respectively in AEC
modes Standard, Dose-, Standard+ and Implant (Tables 7 to 10). The displayed doses
were almost all higher than the calculated MGDs, on average by approximately 5%.
This may be partly accounted for by small differences in measurement, for example the
HVLs in the DICOM headers are 0.37 for 26kV Mo/Mo and 0.57 for 34kV Rh/Ag, slightly
different from the measured values in Table 5.
CNR measurements made with plain PMMA showed a steady decrease with increasing
equivalent breast thickness (Figure 6). Target CNR values of 10.2 and 15.0, for
minimum acceptable and achievable image quality respectively, were calculated. All
CNR values exceeded the European limiting values for CNR (Tables 11 to 12). All AEC
modes exceeded the CNR target for minimum image quality from 20 to 90mm
equivalent breast thicknesses. In the Standard mode the CNR target for achievable
image quality was equalled or exceeded up to 60mm equivalent breast thickness. In
Standard+ mode this target was exceeded up to 75mm equivalent breast thickness.
Consideration should be given to using the Standard mode for breasts up to 60mm thick
and the Standard+ mode for greater thicknesses. The Dose- mode is not recommended
for routine use because of the resulting reduction in image quality.
The European guidelines include a test for whether the SNR remains approximately
constant as the thickness of added PMMA increases. The results (shown in Tables 13
to 15) for Standard, Dose- and Standard+ modes showed that a nearly constant SNR
was maintained for total thicknesses of 36mm and above. At 32 and 34mm thickness, a
lower SNR value was seen, related to the choice of 26kV Mo/Mo as exposure factors for
these thicknesses only. For Implant mode, 34kV Rh/Ag was selected by the AEC for all
thicknesses, and no step in SNR value occurred, but there was a gradual decrease with
total thickness of PMMA, as shown in Table 16.
However, the test for constant SNR is not the most appropriate test for this system.
Since the design aim is to keep CNR constant, rather than SNR, it would be better to
modify the test to include a 0.2mm thick aluminium square, and measure CNR instead.
Noise analysis showed that quantum noise is the main contribution to the noise over a
wide range of incident air kerma (Figure 10). There are minimal contributions from
electronic and structural noise.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
Threshold gold thicknesses for a range of detail diameters are shown in Figure 11. At
an MGD of 1.26mGy (close to that selected for the equivalent thickness of PMMA in
Standard mode), the image quality was very close to the achievable level for all contrast
detail diameters.
Threshold gold thickness measurements at different dose levels for the 0.1mm and
0.25mm diameter details were used to calculate MGDs to a simulated 60mm equivalent
breast required for the minimum and achievable levels of image quality (Figure 12). This
allowed comparisons to be made between this and other systems previously tested.
The dose required for the Pristina to reach the achievable level of image quality was
comparable to that calculated for other digital mammography systems (Table 20).
The detector performance, as indicated by MTF, NNPS and DQE curves (Figures 17 to 19), was
satisfactory.
5. Conclusions
The MGD is well below the remedial level for all AEC modes. In Standard mode, the
MGD to the standard breast (53mm equivalent breast) is 1.19mGy. The image quality,
as measured by threshold gold thickness, is at the achievable level for the Standard
mode.
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Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
References
1. Kulama E, Burch A, Castellano I et al. Commissioning and routine testing of full field
digital mammography systems (NHSBSP Equipment Report 0604, Version 3). Sheffield:
NHS Cancer Screening Programmes, 2009
2. van Engen R, Young KC, Bosmans H, et al. European protocol for the quality control of
the physical and technical aspects of mammography screening. In European guidelines
for quality assurance in breast cancer screening and diagnosis, Fourth Edition.
Luxembourg: European Commission, 2006
4. Moore AC, Dance DR, Evans DS et al. The Commissioning and Routine Testing of
Mammographic X-ray Systems. York: Institue of Physics and Engineering in Medicine,
Report 89, 2005
5. Alsager A, Young KC, Oduko JM. Impact of heel effect and ROI size on the
determination of contrast-to-noise ratio for digital mammography systems. In
Proceedings of SPIE Medical Imaging, Bellingham WA: SPIE Publications, 2008,
691341: 1-11
6. Boone JM, Fewell TR and Jennings RJ. Molybdenum, rhodium and tungsten anode
spectral models using interpolating polynomials with application to mammography
Medical Physics, 1997, 24: 1863-1974
7. Berger MJ, Hubbell JH, Seltzer SM, Chang et al. XCOM: Photon Cross Section
Database (version 1.3) http://physics.nist.gov/xcom (Gaithersburg, MD, National Institute
of Standards and Technology), 2005
8. Young KC, Oduko JM, Bosmans H, Nijs K, Martinez L. Optimal beam quality selection in
digital mammography. British Journal of Radiology, 2006, 79: 981-990
9. Young KC, Cook JH, Oduko JM. Automated and human determination of threshold
contrast for digital mammography systems. In Proceedings of the 8th International
Workshop on Digital Mammography, Berlin: Springer-Verlag, 2006, 4046: 266-272
10. Young KC, Alsager A, Oduko JM et al. Evaluation of software for reading images of the
CDMAM test object to assess digital mammography systems. In Proceedings of SPIE
Medical Imaging, Bellingham WA: SPIE Publications, 2008, 69131C: 1-11
36
Technical evaluation GE Senographe Pristina digital mammography system in 2D mode
11. IEC 62220-1-2, Determination of the detective quantum efficiency – Detectors used in
mammography. International Electrotechnical Commission, 2007
12. Mackenzie A, Oduko JM. Technical evaluation of the Hologic 3Dimensions digital
mammography system in 2D mode. London: Public Health England, 2019
13. Young KC, Oduko JM, Gundogdu O and Asad M. Technical evaluation of profile
automatic exposure control software on GE Essential FFDM systems (NHSBSP
Equipment Report 0903). Sheffield: NHS Cancer Screening Programmes, 2009
15. Oduko JM, Young KC. Technical evaluation of Philips MicroDose L30 with AEC software
version 8.3 (NHSBSP Equipment Report 1305). Sheffield: NHS Cancer Screening
Programmes, 2013
16. Strudley CJ, Oduko JM, Young KC. Technical evaluation of the Fujifilm AMULET
Innovality Digital Mammography System (NHSBSP Equipment Report 1601). London:
Public Health England, 2017
17. Tyler N, Young KC, Oduko JM, Mackenzie A. Technical evaluation of IMS Giotto Class
Digital Mammography System in 2D mode. London: Public Health England, 2019
18. Tyler N, Oduko JM, Strudley C, Mackenzie A. Technical evaluation of planmed Clarity
Digital Mammography System in 2D mode. London: Public Health England, 2019
37