ESR Essentials: diagnostic work-up in patients with symptomatic breast disease-practice recommendations by the European Society of Breast Imaging.

Breast complaints are frequent reasons for consultations in primary care or breast clinics. Breast pain, breast lumps, and nipple discharge are the most common complaints. Less common symptoms such as skin changes and axillary abnormalities also require specific diagnostic approaches. Imaging the symptomatic breast should be performed by appropriately trained breast radiologists following the best practice guidelines and quality standards. Full-field digital mammography (FFDM), digital breast tomosynthesis (DBT), and breast ultrasound (US) are the main modalities used in this primary setting. The choice depends on the patient's age and symptoms. Women younger than 30-years-old are first imaged by US, whereas women over 40-years-old usually require both FFDM or DBT and US. For women between 30-years-old and 40-years-old, the US is the modality of choice, whereas FFDM or DBT might also be performed if needed. Pregnant or lactating women with palpable lesions or nipple discharge are imaged with US as the first method; FFDM or DBT can also be performed depending on the degree of suspicion as the dose to the fetus is minimal, and shielding may even further reduce the dose. More advanced techniques such as breast magnetic resonance imaging or contrast-enhanced mammography are not indicated in this first diagnostic setting and are reserved for cases of established malignancy (local staging) or rare cases of equivocal findings not otherwise resolved or inflammatory breast cancer. Last, but not least, male breast symptoms should also be addressed with US and/or FFDM. CLINICAL RELEVANCE STATEMENT: It is equally important to correctly diagnose an underlying malignancy and to avoid false positives that would lead to unnecessary biopsies, increased costs, and anxiety for the patient. Proper use of imaging modalities ensures optimal diagnostic approach and minimizes false negatives. KEY POINTS: Ultrasound, full-field digital mammography, or digital breast tomosynthesis are the main imaging modalities in the diagnostic setting, while MRI or contrast-enhanced mammography should be reserved to selected cases. Initial imaging modality includes ultrasound combined with mammography or digital breast tomosynthesis depending on women's age and the presence (or not) of inconclusive findings. A negative imaging evaluation should not deter biopsy when a highly suspicious finding is found on physical examination.

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.

US and Digital Breast Tomosynthesis in Women with Focal Breast Complaints: Results of the Breast US Trial (BUST).

Background Digital breast tomosynthesis (DBT) followed by targeted US is commonly performed to evaluate women with localized breast complaints. However, the added value of DBT in addition to targeted US is unknown. Omitting DBT may be cost-effective and improve patient comfort but may miss potential breast cancer. Purpose To assess whether an imaging protocol consisting of targeted US alone may be feasible for the diagnostic work-up of women with localized symptoms and to assess the supplemental value of DBT in this reversed setting. Materials and Methods This prospective study enrolled consecutive women aged 30 years or older with focal breast complaints in three hospitals in the Netherlands between September 2017 and June 2019. In all participants, first, targeted US was evaluated, and if needed, biopsy was performed, followed by DBT. The primary outcome was the frequency of breast cancer detected with DBT when US was negative. Secondary outcomes were frequency of cancer detected with DBT elsewhere in the breast and combined overall sensitivity of US plus DBT. The reference standard was 1 year follow-up or histopathologic examination. Results There were 1961 women (mean age ± SD, 47 years ± 12) enrolled. Based on initial US alone, 1587 participants (81%) had normal or benign findings and 1759 (90%) had a definitive accurate diagnosis. In total, 204 breast cancers were detected during initial work-up. The frequency of malignancy was 10% (192 of 1961 participants) with US (US sensitivity, 98.5% [95% CI: 96, 100]; US specificity, 90.8% [95% CI: 89, 92]). DBT depicted three unobserved malignant lesions at the complaint site and 0.41% (eight of 1961 participants) of incidental malignant findings in participants without symptomatic cancer. Conclusion Compared with combined US and DBT, US was accurate as a stand-alone breast imaging modality in the assessment of focal breast complaints. The rate of cancer detection of cancers elsewhere in the breast with DBT is comparable to cancer detection rate of screening mammography. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Newell in this issue.

Impact of artificial intelligence support on accuracy and reading time in breast tomosynthesis image interpretation: a multi-reader multi-case study.

OBJECTIVES: Digital breast tomosynthesis (DBT) increases sensitivity of mammography and is increasingly implemented in breast cancer screening. However, the large volume of images increases the risk of reading errors and reading time. This study aims to investigate whether the accuracy of breast radiologists reading wide-angle DBT increases with the aid of an artificial intelligence (AI) support system. Also, the impact on reading time was assessed and the stand-alone performance of the AI system in the detection of malignancies was compared to the average radiologist. METHODS: A multi-reader multi-case study was performed with 240 bilateral DBT exams (71 breasts with cancer lesions, 70 breasts with benign findings, 339 normal breasts). Exams were interpreted by 18 radiologists, with and without AI support, providing cancer suspicion scores per breast. Using AI support, radiologists were shown examination-based and region-based cancer likelihood scores. Area under the receiver operating characteristic curve (AUC) and reading time per exam were compared between reading conditions using mixed-models analysis of variance. RESULTS: On average, the AUC was higher using AI support (0.863 vs 0.833; p = 0.0025). Using AI support, reading time per DBT exam was reduced (p < 0.001) from 41 (95% CI = 39-42 s) to 36 s (95% CI = 35- 37 s). The AUC of the stand-alone AI system was non-inferior to the AUC of the average radiologist (+0.007, p = 0.8115). CONCLUSIONS: Radiologists improved their cancer detection and reduced reading time when evaluating DBT examinations using an AI reading support system. KEY POINTS: • Radiologists improved their cancer detection accuracy in digital breast tomosynthesis (DBT) when using an AI system for support, while simultaneously reducing reading time. • The stand-alone breast cancer detection performance of an AI system is non-inferior to the average performance of radiologists for reading digital breast tomosynthesis exams. • The use of an AI support system could make advanced and more reliable imaging techniques more accessible and could allow for more cost-effective breast screening programs with DBT.

Optimized, Person-Centered Workflow Design for a High-Throughput Breast MRI Screening Facility-A Simulation Study.

OBJECTIVES: This project aims to model an optimal scanning environment for breast magnetic resonance imaging (MRI) screening based on real-life data to identify to what extent the logistics of breast MRI can be optimized. MATERIALS AND METHODS: A novel concept for a breast MRI screening facility was developed considering layout of the building, workflow steps, used resources, and MRI protocols. The envisioned screening facility is person centered and aims for an efficient workflow-oriented design. Real-life data, collected from existing breast MRI screening workflows, during 62 scans in 3 different hospitals, were imported into a 3D simulation software for designing and testing new concepts. The model provided several realistic, virtual, logistical pathways for MRI screening and their outcome measures: throughput, waiting times, and other relevant variables. RESULTS: The total average appointment time in the baseline scenario was 25:54 minutes, with 19:06 minutes of MRI room occupation. Simulated improvements consisted of optimizing processes and resources, facility layout, and scanning protocol. In the simulation, time spent in the MRI room was reduced by introducing an optimized facility layout, dockable tables, and adoption of an abbreviated MRI scanning protocol. The total average appointment time was reduced to 19:36 minutes, and in this scenario, the MRI room was occupied for 06:21 minutes. In the most promising scenario, screening of about 68 people per day (10 hours) on a single MRI scanner could be feasible, compared with 36 people per day in the baseline scenario. CONCLUSIONS: This study suggests that by optimizing workflow MRI for breast screening total appointment duration and MRI occupation can be reduced. A throughput of up to 6 people per hour may be achieved, compared with 3 people per hour in the current setup.

Women's Experiences with Digital Breast Tomosynthesis and Targeted Breast Ultrasound for Focal Breast Complaints: A Survey Study.

Background: Owing to its high sensitivity, as concluded in the Breast UltraSound Trial (BUST), targeted ultrasound (US) now seems a promising accurate stand-alone modality for diagnostic evaluation of breast complaints. This approach implies omission of bilateral digital breast tomosynthesis (DBT) in women with clearly benign US findings. Within BUST, radiologists started with US followed by DBT. This side-study investigates women's experiences with DBT, their main motivation to undergo diagnostic imaging, and their view on US as a stand-alone modality. Methods: A subset of BUST participants completed a questionnaire on their DBT experiences, reason for undergoing diagnostic assessment, and view on US-only diagnostics. Responses were analyzed with descriptive statistics and logistic regression analyses. Results: In total, 778 of 838 women (response rate 92.8%) were included (M = 47, SD = 11.16). Of them, 16.8% reported no burden of DBT, 33.5% slight burden, 31.0% moderate, and 12.7% severe burden. Furthermore, 13% reported no pain, 35.3% slight pain, 33.2% moderate, and 11.3% severe pain. Moreover, 88.3% indicated that the most important reason for breast assessment was explanation of their complaint and to rule out breast cancer, whereas 3.2% wanted to "check" both breasts. And 82.4% reported satisfaction with US only in case of a nonmalignancy. Conclusions: Our study shows that most women in the diagnostic setting experience at least slight-to-moderate DBT-related burden and pain, and that explanation for their symptoms is their main interest. Also, the majority report satisfaction with US only in case of nonmalignant findings. However, exploration of women's perspectives outside this study is needed as our participants all underwent both examinations.

Patients' perceptions of targeted breast ultrasound and digital breast tomosynthesis in the diagnostic setting: A mixed methods study.

BACKGROUND: Although DBT is the standard initial imaging modality for women with focal breast symptoms, the importance of ultrasound has grown rapidly in the past decades. Therefore, the Breast UltraSound Trial (BUST) focused on assessing the diagnostic value of ultrasound and digital breast tomosynthesis (DBT) for the evaluation of breast symptoms by reversing the order of breast imaging; first performing ultrasound followed by DBT. This side-study of the BUST evaluates patients' perceptions of ultrasound and DBT in a reversed setting. METHODS: After imaging, 1181/1276 BUST participants completed a survey consisting of open and closed questions regarding both exams (mean age 47.2, ±11.74). Additionally, a different subset of BUST participants (n = 29) participated in six focus group interviews 18-24 months after imaging to analyze their imaging experiences in depth. RESULTS: A total of 55.3% of women reported reluctance to undergoing DBT, primarily due of pain, while the vast majority also find bilateral DBT reassuring (87.3%). Thematic analysis identified themes related to 1) imaging reluctance (pain/burden, result, and breast harm) and 2) ultrasound and DBT perceptions. Regarding the latter, the theme comfort underscores DBT as burdensome and painful, while ultrasound is largely perceived as non-burdensome. Ultrasound is also particularly valued for its interactive nature, as highlighted in the theme interaction. Perceived effectiveness reflects women's interest in bilateral breast evaluation with DBT and the visibility of lesions, while they express more uncertainty about the reliability of ultrasound. Emotional impact portrays DBT as reassuring for many women, whereas opinions on the reassurance provided by ultrasound are more diverse. Additional themes include costs, protocols and privacy. CONCLUSIONS: Ultrasound is highly tolerated, and particularly valued is the interaction with the radiologist. Nearly half of women express reluctance towards DBT; nevertheless, a large portion report feeling more confident after undergoing bilateral DBT, reassuring them of the absence of abnormalities. Understanding patients' perceptions of breast imaging examinations is of great value when optimizing diagnostic pathways.

The Effect of Targeted Ultrasound as Primary Imaging Modality on Quality of Life in Women with Focal Breast Complaints: A Comparative Cohort Study.

Background: The high diagnostic performance of modern breast ultrasound (US) opens the possibility to shift toward targeted US as initial imaging test in women with breast complaints. This comparative cohort study investigates the effects of starting with US followed by digital breast tomosynthesis (DBT), as practiced in the breast ultrasound study (BUST), on women's health-related quality of life (QoL). Methods: Fifty BUST participants and 50 "controls" who underwent DBT and US in regular order filled out the EQ-5D-3L three times during their visit: BUST participants before US (T1), after US (T2), and after DBT (T3) and non-BUST participants before DBT (T1), after DBT (T2), and after US (T3). Changes in QoL from baseline to T2 and T3 were assessed using generalized least squares, also taking into account the effects of biopsy, age, and complaint type. Results: Participants' mean age was 50.6 years (BUST: SD = 12.1, controls: SD = 11.5). At T2 the overall QoL was higher [t(102.9) = 2.4, p = 0.017] and anxiety levels were lower [t(98.7) = -2.4, p = 0.020] in BUST participants compared with controls. However, from T2 to T3 these effects equalize, resulting in similar performances in QoL and anxiety at T3, respectively [t(97.6) = -2.3, p = 0.023] and [t(97.2) = 3.1, p = 0.002]. Compared with BUST participants, controls show a clear decrease in pain after US [t(106.5) = -2.8, p = 0.006]. Women undergoing biopsy had lower QoL [t(167.1) = -2.4, p = 0.017] and pain [t(154.1) = -2.1, p = 0.038], and more anxiety [t(187.4) = 4.3, p = 0.000]. Conclusions: The results suggest that changing the radiological order by starting with US has a short-term positive effect on overall QoL, anxiety, and DBT pain experience in symptomatic women. Owing to its negative impact, biopsies should be performed cautiously. In conclusion, the moment of reassurance for women advances by reversing the radiological order according to the BUST, showing the high importance of human interaction in diagnostic care in addition to the clinical performance of imaging modalities.

Predicting breast cancer types on and beyond molecular level in a multi-modal fashion.

Accurately determining the molecular subtypes of breast cancer is important for the prognosis of breast cancer patients and can guide treatment selection. In this study, we develop a deep learning-based model for predicting the molecular subtypes of breast cancer directly from the diagnostic mammography and ultrasound images. Multi-modal deep learning with intra- and inter-modality attention modules (MDL-IIA) is proposed to extract important relations between mammography and ultrasound for this task. MDL-IIA leads to the best diagnostic performance compared to other cohort models in predicting 4-category molecular subtypes with Matthews correlation coefficient (MCC) of 0.837 (95% confidence interval [CI]: 0.803, 0.870). The MDL-IIA model can also discriminate between Luminal and Non-Luminal disease with an area under the receiver operating characteristic curve of 0.929 (95% CI: 0.903, 0.951). These results significantly outperform clinicians' predictions based on radiographic imaging. Beyond molecular-level test, based on gene-level ground truth, our method can bypass the inherent uncertainty from immunohistochemistry test. This work thus provides a noninvasive method to predict the molecular subtypes of breast cancer, potentially guiding treatment selection for breast cancer patients and providing decision support for clinicians.

Diffusion weighted imaging for evaluation of breast lesions: Comparison between high b-value single-shot and routine readout-segmented sequences at 3 T.

PURPOSE: In this study, we compare readout-segmented echo-planar imaging (rs-EPI) Diffusion Weighted Imaging (DWI) to a work-in-progress single-shot EPI with modified Inversion Recovery Background Suppression (ss-EPI-mIRBS) sequence at 3 T using a b-value of 2000 s/mm2 on image quality, lesion visibility and evaluation time. METHOD: From September 2017 to December 2018, 23 women (one case used for training) with known breast cancer were included in this study, after providing signed informed consent. Women were scanned with the conventional rs-EPI sequence and the work-in-progress ss-EPI-mIRBS during the same examination. Four breast radiologists (4-13 years of experience) independently scored both series for overall image quality (1: extremely poor to 9: excellent). All lesions (47 in total, 36 malignant, and 11 benign and high-risk) were evaluated for visibility (1: not visible, 2: visible if location is given, 3: visible) and probability of malignancy (BI-RADS 1 to 5). ADC values were determined by measuring signal intensity in the lesions using dynamic contrast-enhanced (DCE) images for reference. Evaluation times for all assessments were automatically recorded. Results were analyzed using the visual grading characteristics (VGC) and the resulting area under the curve (AUCVGC) method. Statistical analysis was performed in SPSS, with McNemar tests, and paired t-tests used for comparison. RESULTS: No significant differences were detected between the two sequences in image quality (AUCVGC: 0.398, p = 0.087) and lesion visibility (AUCVGC: 0.534, p = 0.336) scores. Lesion characteristics (e.g benign and high-risk, versus malignant; small (≤10 mm) vs. larger (>10 mm)) did not result in different image quality or lesion visibility between sequences. Sensitivity (rs-EPI: 72.2% vs. ss-EPImIRBS: 78.5%, p = 0.108) and specificity (70.5% vs. 56.8%, p = 0.210, respectively) were comparable. In both sequences the mean ADC value was higher for benign and high-risk lesions than for malignant lesions (ss-EPI-mIRBS: p = 0.022 and rs-EPI: p = 0.055). On average, ss-EPI-mIRBS resulted in decreased overall reading time by 7.7 s/case (p = 0.067); a reduction of 17%. For malignant lesions, average reading time was significantly shorter using ss-EPI-mIRBS compared to rs-EPI (64.0 s/lesion vs. 75.9 s/lesion, respectively, p = 0.039). CONCLUSION: Based on this study, the ss-EPI sequence using a b-value of 2000 s/mm2 enables for a mIRBS acquisition with quality and lesion conspicuity that is comparable to conventional rs-EPI, but with a decreased reading time.

Comparison of simultaneous multi-slice single-shot DWI to readout-segmented DWI for evaluation of breast lesions at 3T MRI.

PURPOSE: To compare diffusion-weighted imaging of the breast performed with a conventional readout-segmented echo-planar imaging (rs-EPI) sequence to when using a prototype simultaneous multi-slice single-shot EPI (SMS-ss-EPI) acquisition. METHOD: From September 2017 to December 2018, 26 women with histologically proven breast cancer were scanned with the conventional rs-EPI and the SMS-ss-EPI at 3 T during the same imaging examination. Four breast radiologists (4-13 years of experience) independently scored both acquired series of 25 women (one case was used for training) for overall image quality (1: extremely poor to 9: excellent) and artifacts (1: very disturbing to 5: not present). All lesions (n = 52; 40 malignant, 12 benign) were also evaluated for visibility (1: not visible, 2: visible if location is given, 3: visible). In addition, lesion characteristics were rated, and a BI-RADS score was given. Results were analyzed using visual grading characteristics and the resulting area under the curve (AUCVGC), weighted kappa, McNemar test, and dependent-samples t-test when appropriate. RESULTS: Overall, radiologists significantly preferred the image quality in rs-EPI over that of SMS-ss-EPI (AUCVGC: 0.698, P = 0.002). Infolding and ghosting, and distortion artifacts were significantly less apparent in the rs-EPI (AUCVGC: 0.660, P = 0.022 and AUCVGC: 0.700 P = 0.002, respectively). Lesions were, however, significantly better visible on the SMS-ss-EPI images (AUCVGC: 0.427, P = 0.016). Malignant lesions had significantly higher visibility with SMS-ss-EPI (P = 0.035). Sensitivity and specificity were comparable between both sequences (P = 0.760 and P = 0.549, respectively). CONCLUSIONS: Despite the perceived lower image quality and the increased presence of artifacts in the SMS-ss-EPI sequence, malignant lesions are better visualized using this sequence.

Compressed Sensing for Breast MRI: Resolving the Trade-Off Between Spatial and Temporal Resolution.

OBJECTIVE: Ultrafast dynamic contrast-enhanced magnetic resonance imaging of the breast enables assessment of the contrast inflow dynamics while providing images with diagnostic spatial resolution. However, the slice thickness of common ultrafast techniques still prevents multiplanar reconstruction. In addition, some temporal blurring of the enhancement characteristics occurs in case view-sharing is used. We evaluate a prototype compressed-sensing volume-interpolated breath-hold examination (CS-VIBE) sequence for ultrafast breast MRI that improves through plane spatial resolution and avoids temporal blurring while maintaining an ultrafast temporal resolution (less than 5 seconds per volume). Image quality (IQ) of the new sequence is compared with an ultrafast view-sharing sequence (time-resolved angiography with interleaved stochastic trajectories [TWIST]), and assessment of lesion morphology is compared with a regular T1-weighted 3D Dixon sequence (VIBE-DIXON) with an acquisition time of 91 seconds. MATERIALS AND METHODS: From April 2016 to October 2016, 30 women were scanned with the CS-VIBE sequence, replacing the routine ultrafast TWIST sequence in a hybrid breast MRI protocol. The need for informed consent was waived. All MRI scans were performed on a 3T MAGNETOM Skyra system (Siemens Healthcare, Erlangen, Germany) using a 16-channel bilateral breast coil. Two reader studies were conducted involving 5 readers. In the first study, overall IQ of CS-VIBE and TWIST in the axial plane was independently rated for 23 women for whom prior MRI examinations with TWIST were available. In addition, the presence of several types of artifacts was rated on a 5-point scale. The second study was conducted in women (n = 16) with lesions. In total, characteristics of 31 lesions (5 malignant and 26 benign) were described independently for CS-VIBE and VIBE-DIXON, according to the BI-RADS MRI-lexicon. In addition, a lesion conspicuity score was given. RESULTS: Using CS-VIBE, a much higher through-plane spatial resolution was achieved in the same acquisition time as with TWIST, without affecting in-plane IQ (P = 0.260). Time-resolved angiography with interleaved stochastic trajectories showed slightly more motion artifacts and infolding and ghosting artifacts compared with CS-VIBE, whereas CS-VIBE showed more breathing and pulsation artifacts. For morphologic assessment, intrareader agreement between CS-VIBE and the more time-consuming VIBE-DIXON was slight to almost perfect, and generally higher than interreader agreement. Mean sensitivity (84.0% and 92.0% for CS-VIBE and VIBE-DIXON, P = 0.500) and specificity (60.0% and 55.4% for CS-VIBE and VIBE-DIXON, P = 0.327) were comparable for both sequences. CONCLUSIONS: Compressed-sensing volume-interpolated breath-hold examination allows an increase of the through-plane spatial resolution of ultrafast dynamic contrast-enhanced magnetic resonance imaging compared with TWIST at a comparable in-plane IQ. Morphological assessment of lesions using CS-VIBE is comparable to VIBE-DIXON, which takes 18 times longer. Consequently, CS-VIBE enables 3D evaluation of breast lesions in ultrafast breast MRI.