Impact of pre-operative MRI on surgical management of screening digital breast tomosynthesis-detected invasive lobular carcinoma.

PURPOSE: The purpose of this study is to determine the impact of pre-operative MRI on surgical management of screening digital breast tomosynthesis (DBT)-detected invasive lobular carcinoma (ILC). METHODS: A retrospective medical record analysis was conducted of women with screening DBT-detected ILC and subsequent surgery from 2017-2021. Clinical, imaging, and pathological features were compared between women who did and did not undergo MRI, and between women with and without additional disease detected on MRI, using the Pearson's chi-squared test and Wilcoxon signed-rank test. Concordance between imaging and surgical pathology sizes was also evaluated. RESULTS: Of 125 women (mean age 67 years, range 44-90) with screening-detected ILC, MRI was obtained in 62 women (49.6%) with a mean age of 63 years (range 45-80). Compared to women without MRI, women who had MRI examinations were younger, more likely to have dense breast tissue, and more likely to undergo mastectomy initially rather than lumpectomy (p < 0.001-0.01). Eighteen biopsies were performed based on MRI findings, of which 55.6% (10/18) were malignant. Conventional imaging more frequently underestimated ILC span at the biopsy site than MRI, using a 25% threshold difference (17.5% [7/40] versus 58.5% [24/41], p < 0.001). MRI detected more extensive disease at the biopsy site in six patients (9.7%, 6/62), additional ipsilateral disease in six patients (9.7%, 6/62), and contralateral disease in one patient (1.6%, 1/62). MRI therefore impacted surgical management in 21.0% (13/62) of patients. CONCLUSION: MRI led to the detection of additional disease, thus impacting surgical management, in one-fifth of patients with ILC.

Impact of super-resolution and image acquisition on the detection of calcifications in digital breast tomosynthesis.

OBJECTIVES: A virtual clinical trial (VCT) method is proposed to determine the limit of calcification detection in tomosynthesis. METHODS: Breast anatomy, focal findings, image acquisition, and interpretation (n = 14 readers) were simulated using screening data (n = 660 patients). Calcifications (0.2-0.4 mm3) were inserted into virtual breast phantoms. Digital breast tomosynthesis (DBT) acquisitions were simulated assuming various acquisition geometries: source motion (continuous and step-and-shoot), detector element size (140 and 70 µm), and reconstructed voxel size (35-140 µm). VCT results were estimated using multiple-reader multiple-case analyses and d' statistics. Signal-to-noise (SNR) analyses were also performed using BR3D phantoms. RESULTS: Source motion and reconstructed voxel size demonstrated significant changes in the performance of imaging systems. Acquisition geometries that use 70 µm reconstruction voxel size and step-and-shoot motion significantly improved calcification detection. Comparing 70 with 100 µm reconstructed voxel size for step-and-shoot, the ΔAUC was 0.0558 (0.0647) and d' ratio was 1.27 (1.29) for 140 µm (70 µm) detector element size. Comparing step-and-shoot with a continuous motion for a 70 µm reconstructed voxel size, the ΔAUC was 0.0863 (0.0434) and the d' ratio was 1.40 (1.19) for 140 µm (70 µm) detector element. Small detector element sizes (e.g., 70 µm) did not significantly improve detection. The SNR results with the BR3D phantom show that calcification detection is dependent upon reconstructed voxel size and detector element size, supporting VCT results with comparable agreement (ratios: d' = 1.16 ± 0.11, SNR = 1.34 ± 0.13). CONCLUSION: DBT acquisition geometries that use super-resolution (smaller reconstructed voxels than the detector element size) combined with step-and-shoot motion have the potential to improve the detection of calcifications. CLINICAL RELEVANCE: Calcifications may not always be discernable in tomosynthesis because of differences in acquisition and reconstruction methods. VCTs can identify strategies to optimize acquisition and reconstruction parameters for calcification detection in tomosynthesis, most notably through super-resolution in the reconstruction. KEY POINTS: • Super-resolution improves calcification detection and SNR in tomosynthesis; specifically, with the use of smaller reconstruction voxels. • Calcification detection using step-and-shoot motion is superior to that using continuous tube motion. • A detector element size of 70 µm does not provide better detection than 140 µm for small calcifications at the threshold of detectability.

Interval cancer in the Córdoba Breast Tomosynthesis Screening Trial (CBTST): comparison of digital breast tomosynthesis plus digital mammography to digital mammography alone.

PURPOSE: This work aims to compare the interval cancer rate and interval cancer characteristics between women screened with digital breast tomosynthesis (DBT) + digital mammography (DM) and those screened with DM alone. METHODS: The interval cancer rate and interval cancer characteristics of the study population included in the Córdoba Breast Tomosynthesis Screening Trial (CBTST) were compared to a contemporary control population screened with DM. The tumour characteristics of screen-detected and interval cancers were also compared. Contingency tables were used to compare interval cancer rates. The chi-square test and Fisher's exact test were used to compare the qualitative characteristics of the cancers whereas Student's t test and the Mann-Whitney U test were used to analyse quantitative features. RESULTS: A total of 16,068 screening exams with DBT + DM were conducted within the CBTST (mean age 57.59 ± 5.9 [SD]) between January 2015 and December 2016 (study population). In parallel, 23,787 women (mean age 58.89 ± 5.9 standard deviation [SD]) were screened with DM (control population). The interval cancer rate was lower in the study population than in the control population (15 [0.93‰; 95% confidence interval (CI): 0.73, 1.14] vs 43 [1.8‰; 95% CI: 1.58, 2.04] respectively; p = 0.045). The difference in rate was more marked in women with dense breasts (0.95‰ in the study population vs 3.17‰ in the control population; p = 0.031). Interval cancers were smaller in the study population than in the control population (p = 0.031). CONCLUSIONS: The interval cancer rate was lower in women screened with DBT + DM compared to those screened with DM alone. These differences were more pronounced in women with dense breasts. CLINICAL RELEVANCE STATEMENT: Women screened using tomosynthesis and digital mammography had a lower rate of interval cancer than women screened with digital mammography, with the greatest difference in the interval cancer rate observed in women with dense breasts. KEY POINTS: • The interval cancer rate was lower in the study population (digital breast tomosynthesis [DBT] + digital mammography [DM]) than in the control population (DM). • The difference in interval cancer rates was more pronounced in women with dense breasts. • Interval cancers were smaller in the study population (DBT + DM) than in the control population (DM).

Take a break: should breaks be enforced during digital breast tomosynthesis reading sessions?

OBJECTIVES: Digital breast tomosynthesis (DBT) can improve diagnostic accuracy compared to 2D mammography, but DBT reporting is time-consuming and potentially more fatiguing. Changes in diagnostic accuracy and subjective and objective fatigue were evaluated over a DBT reporting session, and the impact of taking a reporting break was assessed. MATERIALS AND METHODS: Forty-five National Health Service (NHS) mammography readers from 6 hospitals read a cancer-enriched set of 40 DBT cases whilst eye tracked in this prospective cohort study, from December 2020 to April 2022. Eye-blink metrics were assessed as objective fatigue measures. Twenty-one readers had a reporting break, 24 did not. Subjective fatigue questionnaires were completed before and after the session. Diagnostic accuracy and subjective and objective fatigue measures were compared between the cohorts using parametric and non-parametric significance testing. RESULTS: Readers had on average 10 years post-training breast screening experience and took just under 2 h (105.8 min) to report all cases. Readers without a break reported greater levels of subjective fatigue (44% vs. 33%, p = 0.04), which related to greater objective fatigue: an increased average blink duration (296 ms vs. 286 ms, p < 0.001) and a reduced eye-opening velocity (76 mm/s vs. 82 mm/s, p < 0.001). Objective fatigue increased as the trial progressed for the no break cohort only (ps < 0.001). No difference was identified in diagnostic accuracy between the groups (accuracy: 87% vs. 87%, p = 0.92). CONCLUSIONS: Implementing a break during a 2-h DBT reporting session resulted in lower levels of subjective and objective fatigue. Breaks did not impact diagnostic accuracy, which may be related to the extensive experience of the readers. CLINICAL RELEVANCE STATEMENT: DBT is being incorporated into many mammography screening programmes. Recognising that reporting breaks are required when reading large volumes of DBT studies ensures this can be factored in when setting up reading sessions. TRIAL REGISTRATION: Clinical trials registration number: NCT03733106 KEY POINTS: • Use of digital breast tomosynthesis (DBT) in breast screening programmes can cause significant reader fatigue. • The effectiveness of incorporating reading breaks into DBT reporting sessions, to reduce mammography reader fatigue, was investigated using eye tracking. • Integrating breaks into DBT reporting sessions reduced reader fatigue; however, diagnostic accuracy was unaffected.

Diagnostic performance of 3D automated breast ultrasound (3D-ABUS) in a clinical screening setting-a retrospective study.

OBJECTIVES: To assess the diagnostic performance of 3D automated breast ultrasound (3D-ABUS) in breast cancer screening in a clinical setting. MATERIALS AND METHODS: All patients who had 3D-ABUS between January 2014 and January 2022 for screening were included in this retrospective study. The images were reported by 1 of 6 breast radiologists based on the Breast Imaging Reporting and Data Systems (BI-RADS). The 3D-ABUS was reviewed together with the digital breast tomosynthesis (DBT). Recall rate, biopsy rate, positive predictive value (PPV) and cancer detection yield were calculated. RESULTS: In total, 3616 studies were performed in 1555 women (breast density C/D 95.5% (n = 3455/3616), breast density A/B 4.0% (n = 144/3616), density unknown (0.5% (n = 17/3616)). A total of 259 lesions were detected on 3D-ABUS (87.6% (n = 227/259) masses and 12.4% (n = 32/259) architectural distortions). The recall rate was 5.2% (n = 188/3616) (CI 4.5-6.0%) with only 36.7% (n = 69/188) cases recalled to another date. Moreover, recall declined over time. There were 3.4% (n = 123/3616) biopsies performed, with 52.8% (n = 65/123) biopsies due to an abnormality detected in 3D-ABUS alone. Ten of 65 lesions were malignant, resulting in a positive predictive value (PPV) of 15.4% (n = 10/65) (CI 7.6-26.5%)). The cancer detection yield of 3D-ABUS is 2.77 per 1000 screening tests (CI 1.30-5.1). CONCLUSION: The cancer detection yield of 3D-ABUS in a real clinical screening setting is comparable to the results reported in previous prospective studies, with lower recall and biopsy rates. 3D-ABUS also may be an alternative for screening when mammography is not possible or declined. CLINICAL RELEVANCE STATEMENT: 3D automated breast ultrasound screening performance in a clinical setting is comparable to previous prospective studies, with better recall and biopsy rates. KEY POINTS: • 3D automated breast ultrasound is a reliable and reproducible tool that provides a three-dimensional representation of the breast and allows image visualisation in axial, coronal and sagittal. • The diagnostic performance of 3D automated breast ultrasound in a real clinical setting is comparable to its performance in previously published prospective studies, with improved recall and biopsy rates. • 3D automated breast ultrasound is a useful adjunct to mammography in dense breasts and may be an alternative for screening when mammography is not possible or declined.

Radiation exposure and screening yield by digital breast tomosynthesis compared to mammography: results of the TOSYMA Trial breast density related.

OBJECTIVES: The randomized TOmosynthesis plus SYnthesized MAmmography (TOSYMA) screening trial has shown that digital breast tomosynthesis plus synthesized mammography (DBT + SM) is superior to digital mammography (DM) in invasive breast cancer detection varying with breast density. On the other hand, the overall average glandular dose (AGD) of DBT is higher than that of DM. Comparing the DBT + SM and DM trial arm, we analyzed here the mean AGD and their determinants per breast density category and related them to the respective invasive cancer detection rates (iCDR). METHODS: TOSYMA screened 99,689 women aged 50 to 69 years. Compression force, resulting breast thickness, the calculated AGD obtained from each mammography device, and previously published iCDR were used for comparisons across breast density categories in the two trial arms. RESULTS: There were 196,622 exposures of 49,227 women (DBT + SM) and 197,037 exposures of 49,132 women (DM) available for analyses. Mean breast thicknesses declined from breast density category A (fatty) to D (extremely dense) in both trial arms. However, while the mean AGD in the DBT + SM arm declined concomitantly from category A (2.41 mGy) to D (1.89 mGy), it remained almost unchanged in the DM arm (1.46 and 1.51 mGy, respectively). In relative terms, the AGD elevation in the DBT + SM arm (64.4% (A), by 44.5% (B), 27.8% (C), and 26.0% (D)) was lowest in dense breasts where, however, the highest iCDR were observed. CONCLUSION: Women with dense breasts may specifically benefit from DBT + SM screening as high cancer detection is achieved with only moderate AGD elevations. CLINICAL RELEVANCE STATEMENT: TOSYMA suggests a favorable constellation for screening with digital breast tomosynthesis plus synthesized mammography (DBT + SM) in dense breasts when weighing average glandular dose elevation against raised invasive breast cancer detection rates. There is potential for density-, i.e., risk-adapted population-wide breast cancer screening with DBT + SM. KEY POINTS: Breast thickness declines with visually increasing density in digital mammography (DM) and digital breast tomosynthesis (DBT). Average glandular doses of DBT decrease with increasing density; digital mammography shows lower and more constant values. With the smallest average glandular dose difference in dense breasts, DBT plus SM had the highest difference in invasive breast cancer detection rates.

Radial Scars on Screening Digital Breast Tomosynthesis: Upstaging Rates and Management Strategies.

BACKGROUND. Radial scars are more commonly identified on digital breast tomosynthesis (DBT) than on digital mammography (DM). Nonetheless, universal guidelines for radial scar management in the current era of DBT are lacking. OBJECTIVE. The purpose of this study was to determine the upstaging rates of screening DBT-detected radial scars with and without atypia and to identify features related to upstaging risk. METHODS. This retrospective study included patients who underwent core needle biopsy (CNB) showing a radial scar after screening DBT and DM from January 1, 2013, to December 31, 2020. Patients without surgical excision or at least 2 years of imaging follow-up after CNB were excluded. Rates of upstaging to breast cancer (ductal carcinoma in situ [DCIS] or invasive disease) were compared between radial scars with and without atypia at CNB. Associations of upstaging with patient, imaging, and pathologic variables were explored using standard statistical tests. RESULTS. Of 165 women with 171 radial scars, the final study sample included 153 women (mean age, 56 years; range, 33-83 years) with 159 radial scars that underwent surgical excision (80.5%, 128/159) or at least 2 years of imaging follow-up (19.5%, 31/159). Seven radial scars were upstaged to DCIS and one to invasive disease. Therefore, the up-staging rate of radial scars to cancer was 5.0% (8/159). The upstaging rate of radial scars without atypia at CNB was 1.6% (2/129) and that of radial scars with atypia was 20.0% (6/30) (p < .001). On multivariable analysis, features associated with higher upstaging risk included a prior breast cancer diagnosis (62.5% vs 4.8%; p = .01) and the presence of atypia at CNB (75.0% vs 15.9%; p = .02). The upstaging rate according to mammographic finding type was 7.1% (1/14) for asymmetries, 12.5% (2/16) for masses, 5.3% (5/95) for architectural distortion, and 0.0% (0/34) for calcifications. CONCLUSION. Screening-detected radial scars without atypia at CNB have a low upstaging rate to breast cancer of 1.6%. CLINICAL IMPACT. Imaging surveillance rather than surgery is a reasonable approach for radial scars without atypia, particularly for those presenting as calcifications.

Performance Metrics of Screening Digital Breast Tomosynthesis Based on Years Since a Prior Breast Cancer Diagnosis.

BACKGROUND. Mammography surveillance protocols after breast cancer treatment vary widely. Some practices recommend performing diagnostic mammography for a certain number of years or indefinitely, whereas others recommend returning immediately to screening. OBJECTIVE. This study's objective was to determine performance metrics of screening digital breast tomosynthesis (DBT) in patients who resume screening mammography immediately after breast cancer treatment, based on the number of years since the breast cancer diagnosis. METHODS. This retrospective study included screening DBT examinations performed from January 2013 to June 2019 in patients who resumed screening mammography immediately after a prior breast cancer diagnosis. Multivariable logistic regression models with generalized estimating equations were used to evaluate associations between screening performance metrics and years since the prior breast cancer diagnosis, controlling for age, race and ethnicity, breast density, presence of a prior screening mammogram, and interpreting radiologist. RESULTS. The study included 8090 patients (mean age, 65 ± 11 [SD] years) with a prior breast cancer diagnosis who underwent 30,812 screening DBT examinations during the study period. The cancer detection rate (CDR) was 8.6 per 1000 examinations (265/30,812), abnormal interpretation rate (AIR) was 5.7% (1750/30,812), PPV1 was 15.1% (265/1750), sensitivity was 80.3% (265/330), specificity was 95.1% (28,997/30,482), and false-negative rate was 2.1 per 1000 examinations (65/30,812). CDR showed a significant independent positive association with years since breast cancer diagnosis (adjusted OR, 1.03; 95% CI, 1.01-1.05; p < .001), being lowest more than 2 to up to 3 years after diagnosis (4.9 per 1000 examinations) and highest more than 8 to up to 9 years after diagnosis (11.2 per 1000 examinations). AIR showed a significant independent negative association with years since breast cancer diagnosis (adjusted OR, 0.99; 95% CI, 0.98-1.00; p = .01), being highest 1 year or less after diagnosis (7.5%) and lowest more than 5 to up to 6 years after diagnosis (5.0%). CONCLUSION. Among 8090 patients with a prior breast cancer diagnosis, even though the AIR was higher during the year after diagnosis compared with subsequent years, the AIR remained acceptably low (< 10%) in all years. CLINICAL IMPACT. These results support the study institution's mammographic surveillance protocol for patients with a prior breast cancer diagnosis of returning immediately to DBT screening.

Organizational impact of systemic implementation of digital breast tomosynthesis as a primary test for breast cancer screening in Italy.

PURPOSE: We present a comprehensive investigation into the organizational, social, and ethical impact of implementing digital breast tomosynthesis (DBT) as a primary test for breast cancer screening in Italy. The analyses aimed to assess the feasibility of DBT specifically for all women aged 45-74, women aged 45-49 only, or those with dense breasts only. METHODS: Questions were framed according to the European Network of Health Technology Assessment (EuNetHTA) Screening Core Model to produce evidence for the resources, equity, acceptability, and feasibility domains of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) decision framework. The study integrated evidence from the literature, the MAITA DBT trials, and Italian pilot programs. Structured interviews, surveys, and systematic reviews were conducted to gather data on organizational impact, acceptability among women, reading and acquisition times, and the technical requirements of DBT in screening. RESULTS: Implementing DBT could significantly affect the screening program, primarily due to increased reading times and the need for additional human resources (radiologists and radiographers). Participation rates in DBT screening were similar, if not better, to those observed with standard digital mammography, indicating good acceptability among women. The study also highlighted the necessity for specific training for radiographers. The interviewed key persons unanimously considered feasible tailored screening strategies based on breast density or age, but they require effective communication with the target population. CONCLUSIONS: An increase in radiologists' and radiographers' workload limits the feasibility of DBT screening. Tailored screening strategies may maximize the benefits of DBT while mitigating potential challenges.

The risk-based breast screening (RIBBS) study protocol: a personalized screening model for young women.

The optimal mammography screening strategy for women aged 45-49 years is a matter of debate. We present the RIBBS study protocol, a quasi-experimental, prospective, population-based study comparing a risk- and breast density-stratified screening model (interventional cohort) with annual digital mammography (DM) screening (observational control cohort) in a real-world setting. The interventional cohort consists of 10,269 women aged 45 years enrolled between 2020 and 2021 from two provinces of the Veneto Region (northen Italy). At baseline, participants underwent two-view digital breast tomosynthesis (DBT) and completed the Tyrer-Cuzick risk prediction model. Volumetric breast density (VBD) was calculated from DBT and the lifetime risk (LTR) was estimated by including VBD among the risk factors. Based on VBD and LTR, women were classified into five subgroups with specific screening protocols for subsequent screening rounds: (1) LTR ≤ 17% and nondense breast: biennial DBT; (2) LTR ≤ 17% and dense breast: biennial DBT and ultrasound; (3) LTR 17-30% or LTR > 30% without family history of BC, and nondense breast: annual DBT; (4) LTR 17-30% or > 30% without family history of BC, and dense breast: annual DBT and ultrasound; and (5) LTR > 30% and family history of BC: annual DBT and breast MRI. The interventional cohort is still ongoing. An observational, nonequivalent control cohort of 43,000 women aged 45 years participating in an annual DM screening programme was recruited in three provinces of the neighbouring Emilia-Romagna Region. Cumulative incidence rates of advanced BC at three, five, and ten years between the two cohorts will be compared, adjusting for the incidence difference at baseline.Trial registration This study is registered on Clinicaltrials.gov (NCT05675085).

Deep learning, radiomics and radiogenomics applications in the digital breast tomosynthesis: a systematic review.

BACKGROUND: Recent advancements in computing power and state-of-the-art algorithms have helped in more accessible and accurate diagnosis of numerous diseases. In addition, the development of de novo areas in imaging science, such as radiomics and radiogenomics, have been adding more to personalize healthcare to stratify patients better. These techniques associate imaging phenotypes with the related disease genes. Various imaging modalities have been used for years to diagnose breast cancer. Nonetheless, digital breast tomosynthesis (DBT), a state-of-the-art technique, has produced promising results comparatively. DBT, a 3D mammography, is replacing conventional 2D mammography rapidly. This technological advancement is key to AI algorithms for accurately interpreting medical images. OBJECTIVE AND METHODS: This paper presents a comprehensive review of deep learning (DL), radiomics and radiogenomics in breast image analysis. This review focuses on DBT, its extracted synthetic mammography (SM), and full-field digital mammography (FFDM). Furthermore, this survey provides systematic knowledge about DL, radiomics, and radiogenomics for beginners and advanced-level researchers. RESULTS: A total of 500 articles were identified, with 30 studies included as the set criteria. Parallel benchmarking of radiomics, radiogenomics, and DL models applied to the DBT images could allow clinicians and researchers alike to have greater awareness as they consider clinical deployment or development of new models. This review provides a comprehensive guide to understanding the current state of early breast cancer detection using DBT images. CONCLUSION: Using this survey, investigators with various backgrounds can easily seek interdisciplinary science and new DL, radiomics, and radiogenomics directions towards DBT.

Challenges and Changes of the Breast Cancer Screening Paradigm.

Since four decades mammography is used for early breast cancer detection in asymptomatic women and still remains the gold standard imaging modality. However, population screening programs can be personalized and women can be divided into different groups based on risk factors and personal preferences. The availability of new and evolving imaging modalities, for example, digital breast tomosynthesis, dynamic-contrast-enhanced magnetic resonance imaging (MRI), abbreviated MRI protocols, diffusion-weighted MRI, and contrast-enhanced mammography leads to new challenges and perspectives regarding the feasibility and potential harms of breast cancer screening. The aim of this review is to discuss the current guidelines for different risk groups, to analyze the recent published studies about the diagnostic performance of the imaging modalities and to discuss new developments and future perspectives. LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY: Stage 6.

Impact of real-life use of artificial intelligence as support for human reading in a population-based breast cancer screening program with mammography and tomosynthesis.

OBJECTIVES: To evaluate the impact of using an artificial intelligence (AI) system as support for human double reading in a real-life scenario of a breast cancer screening program with digital mammography (DM) or digital breast tomosynthesis (DBT). MATERIAL AND METHODS: We analyzed the performance of double reading screening with mammography and tomosynthesis after implementarion of AI as decision support. The study group consisted of a consecutive cohort of 1 year screening between March 2021 and March 2022 where double reading was performed with concurrent AI support that automatically detects and highlights lesions suspicious of breast cancer in mammography and tomosynthesis. Screening performance was measured as cancer detection rate (CDR), recall rate (RR), and positive predictive value (PPV) of recalls. Performance in the study group was compared using a McNemar test to a control group that included a screening cohort of the same size, recorded just prior to the implementation of AI. RESULTS: A total of 11,998 women (mean age 57.59 years ± 5.8 [sd]) were included in the study group (5049 DM and 6949 DBT). Comparing global results (including DM and DBT) of double reading with vs. without AI support, we observed an increase in CDR, PPV, and RR by 3.2/‰ (5.8 vs. 9; p < 0.001), 4% (10.6 vs. 14.6; p < 0.001), and 0.7% (5.4 vs. 6.1; p < 0.001) respectively. CONCLUSION: AI used as support for human double reading in a real-life breast cancer screening program with DM and DBT increases CDR and PPV of the recalled women. CLINICAL RELEVANCE STATEMENT: Artificial intelligence as support for human double reading improves accuracy in a real-life breast cancer screening program both in digital mammography and digital breast tomosynthesis. KEY POINTS: • AI systems based on deep learning technology offer potential for improving breast cancer screening programs. • Using artificial intelligence as support for reading improves radiologists' performance in breast cancer screening programs with mammography or tomosynthesis. • Artificial intelligence used concurrently with human reading in clinical screening practice increases breast cancer detection rate and positive predictive value of the recalled women.

Discordant and false-negative interpretations at digital breast tomosynthesis in the prospective Oslo Tomosynthesis Screening Trial (OTST) using independent double reading.

OBJECTIVES: To analyze discordant and false-negatives of double reading digital breast tomosynthesis (DBT) versus digital mammography (DM) including reading times in the Oslo Tomosynthesis Screening Trial (OTST), and reclassify these in a retrospective reader study as missed, minimal sign, or true-negatives. METHODS: The prospective OTST comparing double reading DBT vs. DM had paired design with four parallel arms: DM, DM + computer aided detection, DBT + DM, and DBT + synthetic mammography. Eight radiologists interpreted images in batches using a 5-point scale. Reading time was automatically recorded. A retrospective reader study including four radiologists classified screen-detected cancers with at least one false-negative score and screening examinations of interval cancers as negative, non-specific minimal sign, significant minimal sign, and missed; the two latter groups are defined "actionable." Statistics included chi-square, Fisher's exact, McNemar's, and Mann-Whitney U tests. RESULTS: Discordant rate (cancer missed by one reader) for screen-detected cancers was overall comparable (DBT (31% [71/227]) and DM (30% [52/175]), p = .81), significantly lower at DBT for spiculated cancers (DBT, 19% [20/106] vs. DM, 36% [38/106], p = .003), but high (28/49 = 57%, p = 0.001) for DBT-only detected spiculated cancers. Reading time and sensitivity varied among readers. False-negative DBT-only detected spiculated cancers had shorter reading time than true-negatives in 46% (13/28). Retrospective evaluation classified the following DBT exams "actionable": three missed by both readers, 95% (39/41) of discordant cancers detected by both modes, all 30 discordant DBT-only cancers, 25% (13/51) of interval cancers. CONCLUSIONS: Discordant rate was overall comparable for DBT and DM, significantly lower at DBT for spiculated cancers, but high for DBT-only detected spiculated lesions. Most false-negative screen-detected DBT were classified as "actionable." CLINICAL RELEVANCE STATEMENT: Retrospective evaluation of false-negative interpretations from the Oslo Tomosynthesis Screening Trial shows that most discordant and several interval cancers could have been detected at screening. This underlines the potential for modern AI-based reading aids and triage, as high-volume screening is a demanding task. KEY POINTS: • Digital breast tomosynthesis (DBT) screening is more sensitive and has higher specificity compared to digital mammography screening, but high-volume DBT screening is a demanding task which can result in high discordance rate among readers. • Independent double reading DBT screening had overall comparable discordance rate as digital mammography, lower for spiculated masses seen on both modalities, and higher for small spiculated cancer seen only on DBT. • Almost all discordant digital breast tomosynthesis-detected cancers (72 of 74) and 25% (13 of 51) of the interval cancers in the Oslo Tomosynthesis Screening Trial were retrospectively classified as actionable and could have been detected by the readers.

Mammography and Digital Breast Tomosynthesis in Granulomatous and Nongranulomatous Mastitis.

INTRODUCTION: Digital Mammography (DM) is extensively used for breast imaging however, lesion visibility is often limited by overlapping tissues, which affects lesion characterization. Digital breast tomosynthesis (DBT) reduces the effect of overlapping tissues and helps in revealing obscured findings. We aimed to describe the mammographic findings in granulomatous and non-granulomatous mastitis and assess the utility of adjunctive DBT in lesion characterization. MATERIALS AND METHODS: DM and DBT images of histo-pathologically diagnosed cases of granulomatous (GM) and non-granulomatous mastitis (NGM) were reviewed according to the BI-RADS lexicon. Presence of contiguous/ interconnected lesions, tubular densities, interspersed hypodensities/fat densities within the involved areas were also assessed. The perceived utility of adjunct DBT was scored from 0-2. RESULTS: Of 33 reviewed patients (24 GM, 9 NGM; median age 39 years, range 24-78); 13/33 (39.4%) were under 35 years of age. DBT detected masses in 24/33 (72.7%), whereas only 15/33 (45.4%) were visible on DM alone. Contiguous or inter-connected lesions were found in 10/33 (30.3%) cases. Tubular extensions were seen in 14 cases and interspersed hypodensities in 15. None of the enlarged lymph nodes had irregular shape or indistinct margins or loss of fatty hilum. DBT was able to categorize more lesions as BIRADS 4a or below, as compared to DM alone. CONCLUSIONS: Mammographic presence of multiple contiguous iso-dense masses, reniform contour of axillary lymph nodes with preserved fatty hilum despite a large area of breast involvement favour a benign etiology; especially if DBT reveals tubular extensions or lesions with inhomogenous low density areas within.

Pathologic Outcomes in Single Versus Multiple Areas of Architectural Distortion on Digital Breast Tomosynthesis.

BACKGROUND. Digital breast tomosynthesis (DBT) has led to increased detection of architectural distortion (AD). Management of patients with multiple areas of AD is not established. OBJECTIVE. The purpose of this article is to compare pathologic outcomes between single and multiple areas of AD identified on DBT. METHODS. This retrospective study included 402 patients (mean age, 56 years) who underwent image-guided core needle biopsy of AD visualized on DBT between April 7, 2017, and April 16, 2019. Patients were classified as having a single or multiple areas of AD according to the presence of distinct areas of AD described in the clinical radiology reports. The pathologic diagnosis for each AD was on the basis of the most aggressive pathology identified on either biopsy or surgical excision, if performed. Patients with single and multiple areas of AD were compared. RESULTS. The sample included 372 patients with a single AD (145 benign, 121 high risk, 105 malignant, one other) and 30 patients with multiple visualized ADs, including 66 biopsied ADs (10 benign, 35 high risk, 21 malignant). At pathologic assessment on a per-lesion basis, multiple compared with single ADs showed higher frequency of high-risk pathology (53.0% vs 32.5%, p = .002) but no difference in frequency of malignancy (31.8% vs 28.2%, p = .56). In multivariable analysis of a range of patient-related characteristics, the presence of single versus multiple areas of AD was not independently associated with malignancy (p = .51). In patients with multiple areas of AD, the most aggressive pathology (benign, high risk, or malignant) across all ADs was not associated with the number of ADs (p = .73). In 8 of 24 patients with at least two ipsilateral biopsied ADs, the ipsilateral areas varied in terms of most aggressive pathology; in 5 of 10 patients with contralateral biopsied ADs, the contralateral areas varied in most aggressive pathology. CONCLUSION. The presence of multiple areas of AD, compared with a single AD, was significantly more likely to yield high-risk pathology but was not significantly different in yield of malignancy. In patients with multiple ADs, multiple ipsilateral or contralateral ADs commonly varied in pathologic classification (benign, high risk, or malignant). CLINICAL IMPACT. These findings may help guide management of AD visualized by DBT, including multiple ADs. For patients with multiple areas of AD, biopsy of all areas may be warranted given variation in pathologic diagnoses.

Comparison of Diagnostic Mammography-Guided Biopsy and Digital Breast Tomosynthesis-Guided Biopsy of Suspicious Breast Calcifications: Results in 1354 Biopsies.

BACKGROUND. Studies have shown improved targeting and sampling of noncalcified lesions (asymmetries, masses, and architectural distortion) with digital breast tomosynthesis (DBT)-guided biopsy in comparison with digital mammography (DM)-guided stereotactic biopsy. Literature that compares the two techniques specifically for sampling calcifications has been scarce. OBJECTIVE. The purpose of this study was to compare the performance and outcomes of DM- and DBT-guided biopsy of suspicious calcifications. METHODS. This retrospective study included 1310 patients (mean age, 58 ± 12 [SD] years) who underwent a total of 1354 9-gauge vacuum-assisted core biopsies of suspicious calcifications performed at a single institution from May 22, 2017, to December 31, 2021. The decision to use a DM-guided or DBT-guided technique was made at the discretion of the radiologist performing the biopsy. Procedure time, the number of exposures during the procedure, and the histopathologic outcomes were recorded. The two techniques were compared using a two-sample t test for continuous variables and a chi-square test for categoric variables. Additional tests were performed using generalized estimating equations to control for the effect of the individual radiologist performing the biopsy. RESULTS. A total of 348 (26%) biopsies used DM guidance, and 1006 (74%) used DBT guidance. The mean procedure time was significantly lower for DBT-guided biopsy (14.9 ± 8.0 [SD] minutes) than for DM-guided biopsy (24.7 ± 14.3 minutes) (p < .001). The mean number of exposures was significantly lower for DBT-guided biopsy (4.1 ± 1.0 [SD] exposures) than for DM-guided biopsy (9.1 ± 3.3 exposures) (p < .001). The differences in procedure time and number of exposures remained significant (both p < .001) when controlling for the effect of the radiologist performing the biopsy. There were no significant differences (all p > .05) between DM-guided and DBT-guided biopsy in terms of the malignancy rate on initial biopsy (20% vs 19%), the rate of high-risk lesion upgrading (14% vs 22%), or the final malignancy rate (23% vs 22%). CONCLUSION. DBT-guided biopsy of suspicious calcifications can be performed with shorter procedure time and fewer exposures compared with DM-guided biopsy, without a significant difference in rates of malignancy or high-risk lesion upgrading. CLINICAL IMPACT. The use of a DBT-guided, rather than a DM-guided, biopsy technique for suspicious calcifications can potentially reduce patient discomfort and radiation exposure without affecting clinical outcomes.

Frequency and Outcomes of BI-RADS Category 3 Assessments in Patients With a Personal History of Breast Cancer: Full-Field Digital Mammography Versus Digital Breast Tomosynthesis.

BACKGROUND. Studies establishing the validity of BI-RADS category 3 excluded patients with personal history of breast cancer (PHBC). Use of category 3 in patients with PHBC may be impacted not only by this population's increased breast cancer risk, but also by adoption of digital breast tomosynthesis (DBT) over full-field digital mammography (FFDM). OBJECTIVE. The purpose of this article was to compare the frequency, outcomes, and additional characteristics of BI-RADS category 3 assessments between FFDM and DBT in patients with PHBC. METHODS. This retrospective study included 14,845 mammograms in 10,118 patients (mean age, 63 years) with PHBC who had undergone mastectomy and/or lumpectomy. Of these, 8422 examinations were performed by FFDM from October 2014 to September 2016, and 6423 examinations by FFDM with DBT from February 2017 to December 2018, after interval conversion of the center's mammography units. Information was extracted from the EHR and radiology reports. FFDM and DBT groups were compared in the entire sample and among index category 3 lesions (i.e., earliest category 3 assessment per lesion). RESULTS. The frequency of category 3 assessment was lower for DBT than FFDM (5.6% vs 6.4%; p = .05). DBT, compared with FFDM, showed a lower malignancy rate for category 3 lesions (1.8% vs 5.0%; p = .04), higher malignancy rate for category 4 lesions (32.0% vs 23.2%; p = .03), and no difference in malignancy rate for category 5 lesions (100.0% vs 75.0%; p = .24). Analysis of index category 3 lesions included 438 and 274 lesions for FFDM and DBT, respectively. For category 3 lesions, DBT, compared with FFDM, showed lower PPV3 (13.9% vs 36.1%; p = .02) and a more frequent mammographic finding of mass (33.2% vs 23.1%; p = .003). CONCLUSION. The malignancy rate for category 3 lesions in patients with PHBC was less than the accepted limit (2%) for DBT (1.8%), but not FFDM (5.0%). A lower malignancy rate for category 3 lesions but higher malignancy rate for category 4 lesions for DBT supports more appropriate application of category 3 assessment in patients with PHBC through use of DBT. CLINICAL IMPACT. These insights may help establish whether category 3 assessments in patients with PHBC are within benchmarks for early detection of second cancers and reduction of benign biopsies.

Clinical performance of digital breast tomosynthesis-guided vacuum-assisted biopsy: a single-institution experience in Japan.

BACKGROUND: The purpose of this study was to evaluate the clinical performance of Digital Breast Tomosynthesis guided vacuum-assisted biopsy (DBT-VAB) for microcalcifications in the breast. METHODS: Retrospective review of 131 mammography-guided VABs at our institution were performed. All of the targets were calcification lesion suspicious for cancer. 45 consecutive stereotactic vacuum-assisted biopsies (ST-VABs) and 86 consecutive DBT-VABs were compared. Written informed consent was obtained. Tissue sampling methods and materials were the same with both systems. Student's t-test was used to compare procedure time and the Fisher's exact test was used to compare success rate, complications, and histopathologic findings for the 2 methods. RESULTS: The tissue sampling success rate was 95.6% for ST-VAB (43/45) and 97.7% (84/86) for DBT-VAB. Time for positioning (10.6 ± 6.4 vs. 6.7 ± 5.3 min), time for biopsy (33.4 ± 13.1 vs. 22.5 ± 13.1 min), and overall procedure time (66.6 ± 16.6 min vs. 54.5 ± 13.0 min) were substantially shorter with DBT-VAB (P < 0.0001). There were no differences in the distribution of pathological findings between the 2 groups. CONCLUSION: Depth information and stable visibility of the target provided by DBT images led to quick decisions about target coordinates and improved the clinical performance of microcalcification biopsies.

Comparing image quality of five breast tomosynthesis systems based on radiologists' reviews of phantom data.

BACKGROUND: Previous studies have shown differences in technical image quality between digital breast tomosynthesis (DBT) systems. However, quantitative image quality measurements may not necessarily fully reflect the clinical performance of DBT. PURPOSE: To study the subjective image quality of five DBT systems manufactured by Fujifilm, GE, Hologic, Planmed, and Siemens using phantom images. MATERIAL AND METHODS: A TOR MAM test object with polymethyl methacrylate plates was imaged on five DBT systems from different vendors. Three DBT acquisitions were performed at mean glandular doses of 1.0 mGy, 2.0 mGy, and 3.5 mGy while maintaining a constant phantom set-up. Eight DBT acquisitions with different test plate positions and phantom set-up thicknesses were performed at clinically applied dose levels. Additionally, three conventional two-dimensional mammogram images were acquired with different phantom thicknesses. Six radiologists ranked the systems based on the visibilities of the targets seen in the phantom images. RESULTS: In the DBT acquisitions performed at comparable dose levels, one system differed significantly from all other systems in microcalcification scores. When using site-specific DBT protocols, significant differences were found between the devices for microcalcification, filament, and low-contrast targets. A strong correlation was observed between the reviewer scores and radiation doses in DBT acquisitions, whereas no such correlation was observed in the 2D acquisitions. CONCLUSION: In DBT acquisitions, dose level was found to be a major factor explaining image quality differences between the systems, regardless of other acquisition parameters. Most DBT systems performed equally well at similar dose levels.