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.

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.

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.