Audit of data from examination image headers collected for quality assurance in the ECOG-ACRIN EA1151 tomosynthesis mammographic imaging screening trial (TMIST).

PURPOSE: A comprehensive, centrally-monitored physics quality control (QC) program was developed for the Tomosynthesis Imaging Screening Trial (TMIST), a randomized controlled trial of digital breast tomosynthesis (TM) versus digital mammography (DM) for cancer screening. As part of the program, in addition to a set of phantom-based tests, de-identified data on image acquisition and processing parameters were captured from the DICOM headers of all individual patient images in the trial. These data were analyzed to assess the potential usefulness of header data from digital mammograms and tomosynthesis images of patients for quality assurance in breast imaging. METHODS: Data were automatically extracted from the headers of all de-identified patient mammograms and tomosynthesis images in the TMIST study. Image acquisition parameters and estimated radiation doses were tracked for individual sites, systems and across system types. These parameters included (among others) kV, target/filter use, number of acquired views per examination, AEC mode, compression thickness and force and detector temperature. Consistency of manually entered study data parameters (subject ID, screening time-point) from TMIST was evaluated. Preliminary observations from the program are presented. RESULTS: We report on data from 812 651 images from 135 525 examinations acquired between October, 2017 and December, 2022. Data came from 6 system models from 3 manufacturers. There was greater variability both in the number of views used and in the estimated (proxy) doses received in DM exams compared to TM. Mean proxy doses per examination varied among manufacturers from 2.76-4.54 mGy for DM and 3-4.84 mGy for the tomosynthesis component in the TM arm with maximum examination proxy doses of 20 and 26 mGy for DM and TM respectively. Mean proxy doses per examination for the combination examination in TM (tomosynthesis plus digital mammography) varied from 6.6 to 7.6 mGy among manufacturers with a maximum of 44.5 mGy. CONCLUSIONS: Overall, modern digital mammography and tomosynthesis systems used in TMIST have operated very reliably. Doses vary considerably due to variation in the number of views per examination, thickness and fibro-glandularity of the breast, and choices in the use of synthesized versus actual 2D mammography in the TM examination. These data may also be useful in predicting equipment problems. Header information is valuable not only for automated QC, but also for cross-checking accuracy and consistency of data in a clinical study.

Quality control for digital tomosynthesis in the ECOG-ACRIN EA1151 TMIST trial.

BACKGROUND: The Tomosynthesis Mammography Imaging Screening Trial (TMIST), EA1151 conducted by the Eastern Cooperative Oncology Group (ECOG)/American College of Radiology Imaging Network (ACRIN) is a randomized clinical trial designed to assess the effectiveness for breast cancer screening of digital breast tomosynthesis (TM) compared to digital mammography (DM). Equipment from multiple vendors is being used in the study. PURPOSE: For the findings of the study to be valid and capture the true capacities of the two technology types, it is important that all equipment is operated within appropriate parameters with regard to image quality and dose. A harmonized QC program was established by a core physics team. Since there are over 120 trial sites, a centralized, automated QC program was chosen as the most practical design. This report presents results of the weekly QC testing program. A companion paper will review quality monitoring based on data from the headers of the patient images. METHODS: Study images are collected centrally after de-identification using the "TRIAD" application developed by ACR. The core physics team devised and implemented a minimal set of quality control (QC) tests to evaluate the tomosynthesis and 2D mammography systems. Weekly, monthly and annual testing is performed by the site mammography technologists with images submitted directly to the physics core. The weekly physics QC tests are described: SDNR of a low-contrast mass object, artifact spread, spatial resolution, tracking of technical factors, and in-slice noise power spectra. RESULTS: As of December 31, 2022 (5 years), 145 sites with 411 machines had submitted QC data. A total of 136 742 TMIST participant screening imaging studies had been performed. The 5th and 95th percentile mean glandular doses for a single tomosynthesis exposure to a 4.0 cm thick PMMA phantom ("standard breast phantom") were 1.24 and 1.68 mGy respectively. The largest sources of QC non-conformance were: operator error, not following the QC protocol exactly, unreported software updates and preventive maintenance activities that affected QC setpoints. Noise power spectra were measured, however, standardization of performance targets across machine types and software revisions was difficult. Nevertheless, for each machine type, test measurement results were very consistent when the protocol was followed. Deviations in test results were mostly related to software and hardware changes. CONCLUSION: Most systems performed very consistently. Although this is a harmonized program using identical phantoms and testing protocols, it is not appropriate to apply universal threshold or target metrics across the machine types because the systems have different non-linear reconstruction algorithms and image display filters. It was found to be more useful to assess pass/fail criteria in terms of relative deviations from baseline values established when a system is first characterized and after equipment is changed. Generally, systems which needed repair failed suddenly, but in retrospect, for a few cases, drops in SDNR and increases in mAs were observed prior to tube failure. TMIST is registered as NCT03233191 by Clinicaltrials.gov.

Investigating the feasibility of stratified breast cancer screening using a masking risk predictor.

BACKGROUND: Women with dense breasts face a double risk for breast cancer; they are at a higher risk for development of breast cancer than those with less dense breasts, and there is a greater chance that mammography will miss detection of a cancer in dense breasts due to the masking effect of surrounding fibroglandular tissue. These women may be candidates for supplemental screening. In this study, a masking risk model that was previously developed is tested on a cohort of cancer-free women to assess potential efficiency of stratification. METHODS: Three masking risk models based on (1) BI-RADS density, (2) volumetric breast density (VBD), and (3) a combination of VBD and detectability were applied to stratify the mammograms of 1897 cancer-free women. The fraction of cancer-free women whose mammograms were deemed by the algorithm to be masked and who would be considered for supplemental imaging was computed as was the corresponding fraction in a screened population of interval (masked) cancers that would be potentially detected by supplemental imaging. RESULTS: Of the models tested, the combined VBD/detectability model offered the highest efficiency for stratification to supplemental imaging. It predicted that 725 supplemental screens would be performed per interval cancer potentially detected, at an operating point that allowed detection of 64% of the interval cancers. In comparison, stratification based on the upper two BI-RADS density categories required 1117 supplemental screenings per interval cancer detected to capture 64% of interval cancers. CONCLUSION: The combined VBD/detectability models perform better than BI-RADS and offer a continuum of operating points, suggesting that this model may be effective in guiding a stratified screening environment.

Prediction of Cancer Masking in Screening Mammography Using Density and Textural Features.

RATIONALE AND OBJECTIVES: High mammographic density reduces the diagnostic accuracy of screening mammography due to masking of tumors, resulting in possible delayed diagnosis and missed cancers. Women with high masking risk could be preselected for alternative screening regimens less susceptible to masking. In this study, various models to predict masking status are presented based on biometric and image-based parameters. MATERIALS AND METHODS: For a cohort of 67 nonscreen-detected (cancers detected via other means after a negative mammogram) and 147 screen-detected invasive cancers, quantitative volumetric breast density, BI-RADS density, and the distribution and appearance of dense tissue through statistical and texture metrics were measured. Age and Body Mass Index were recorded. Stepwise multivariate logistic regressions were computed to select those parameters that predicted nonscreen-detected cancers. Accuracy of the models was evaluated using the area under receiver operator characteristic curve (AUC). RESULTS: Using BI-RADS density alone to predict masking risk yielded an AUC of 0.64 (95% confidence interval [0.57-0.70]). Age-adjusted BI-RADS density or volumetric breast density had AUCs of 0.72 [0.64-0.79] and 0.71 [0.62-0.78], respectively. A model extracted from the full pool of variables had an AUC of 0.75 [0.67-0.82]. CONCLUSION: The optimal model predicts masking more accurately than density alone, suggesting that texture metrics may be useful in models to guide a stratified screening strategy.

Quantifying masking in clinical mammograms via local detectability of simulated lesions.

PURPOSE: High mammographic density is known to be associated with decreased sensitivity of mammography. Recent changes in the BI-RADS density assessment address the effect of masking by densities, but the BI-RADS assessment remains qualitative and achieves only moderate agreement between radiologists. An automated, quantitative algorithm that estimates the likelihood of masking of simulated masses in a mammogram by dense tissue has been developed. The algorithm considers both the effects of loss of contrast due to density and the distracting texture or appearance of dense tissue. METHODS: A local detectability (dL) map is created by tessellating the mammograms into overlapping regions of interest (ROIs), for which the detectability by a non-prewhitening observer is computed using local estimates of the noise power spectrum and volumetric breast density (VBD). The dL calculation was validated in a 4-alternative forced-choice observer study on the ROIs of 150 craniocaudal digital mammograms. The dL metric was compared against the inverse threshold contrast, (ΔµT)(-1) from the observer study, the anatomic noise parameter ß, the radiologist's BI-RADS density category, and a validated measure of VBD (Cumulus). RESULTS: The mean dL had a high correlation of r = 0.915 and r = 0.699 with (ΔµT)(-1) in the computerized and human observer study, respectively. In comparison, the local VBD estimate had a low correlation of 0.538 with (ΔµT)(-1). The mean dL had a correlation of 0.663, 0.835, and 0.696 with BI-RADS density, ß, and Cumulus VBD, respectively. CONCLUSIONS: The proposed dL metric may be useful in characterizing the potential for lesion masking by dense tissue. Because it uses information about the anatomic noise or tissue appearance, it is more closely linked to lesion detectability than VBD metrics.

Reliability of automated breast density measurements.

PURPOSE: To estimate the reliability of a reference standard two-dimensional area-based method and three automated volumetric breast density measurements by using repeated measures. MATERIALS AND METHODS: Thirty women undergoing screening mammography consented to undergo a repeated left craniocaudal examination performed by a second technologist in this prospective institutional review board-approved HIPAA-compliant study. Breast density was measured by using an area-based method (Cumulus ABD) and three automated volumetric methods (CumulusV [University of Toronto], Volpara [version 1.4.5; Volpara Solutions, Wellington, New Zealand), and Quantra [version 2.0; Hologic, Danbury, Conn]). Discrepancy between the first and second breast density measurements (Δ1-2) was obtained for each algorithm by subtracting the second measurement from the first. The Δ1-2 values of each algorithm were then analyzed with a random-effects model to derive Bland-Altman-type limits of measurement agreement. RESULTS: Variability was higher for Cumulus ABD and CumulusV than for Volpara or Quantra. The within-breast density measurement standard deviations were 3.32% (95% confidence interval [CI]: 2.65, 4.44), 3.59% (95% CI: 2.86, 4.48), 0.99% (95% CI: 0.79, 1.33), and 1.64% (95% CI: 1.31, 1.39) for Cumulus ABD, CumulusV, Volpara, and Quantra, respectively. Although the mean discrepancy between repeat breast density measurements was not significantly different from zero for any of the algorithms, larger absolute breast density discrepancy (Δ1-2) values were associated with larger breast density values for Cumulus ABD and CumulusV but not for Volpara and Quantra. CONCLUSION: Variability in a repeated measurement of breast density is lowest for Volpara and Quantra; these algorithms may be more suited to incorporation into a risk model.

MRI volumetric analysis of breast fibroglandular tissue to assess risk of the spared nipple in BRCA1 and BRCA2 mutation carriers.

OBJECTIVE: Prophylactic nipple-areolar complex (NAC)-sparing mastectomy (NSM) in BRCA1/2 mutation carriers is controversial over concern regarding residual fibroglandular tissue (FGT) with malignant potential. The objective of this study was to model the volume of FGT in the NAC at a standard retroareolar margin (5 mm) and examine the change in this amount with a greater retroareolar margin or areola-sparing technique. METHODS: A segmentation protocol was applied to breast MRIs from 105 BRCA1/2 patients to quantify volumes of FGT for total breast and NAC. The proportion of FGT in the NAC relative to the breast was calculated as the primary outcome and was compared for 5 mm versus 10 mm retroareolar depths. The proportion of FGT in the areola was compared with the NAC. RESULTS: At 5 mm retroareolar thickness, residual NAC FGT comprised 1.3 % of the total breast FGT. This amount was not significantly greater than the proportion in the areola (p = 0.3, d = 0.1). Increasing the retroareolar thickness to 10 mm led to a statistically and possibly clinically significant increase in the amount of NAC FGT (p < 0.001, d = 1.1). CONCLUSIONS: The proportion of FGT remaining in the spared NAC with a 5 mm margin is extremely small, suggesting that leaving the entire NAC would create very little added risk. Doubling the retroareolar margin may translate into a clinically meaningful increase. Overall, our findings support the safety of the current trend toward increased rates of prophylactic NSM performed in this high-risk population.