Abstract Objective To evaluate the diagnostic accuracy of supplemental 3D automated breast ultrasound (ABUS) in the diagnostic work-up of BI-RADS 0 recalls. We hypothesized that 3D ABUS may reduce the benign biopsy rate. Materials and methods In this prospective multicenter diagnostic study, screening participants recalled after a BI-RADS 0 result underwent bilateral 3D ABUS supplemental to usual care: digital breast tomosynthesis (DBT) and targeted hand-held ultrasound (HHUS). Sensitivity, specificity, positive predictive value, and negative predictive value of 3D ABUS, and DBT plus HHUS, were calculated. New 3D ABUS findings and changes of management (biopsy or additional imaging) were recorded. Results A total of 501 women (median age 55 years, IQR [51–64]) with 525 BI-RADS 0 lesions were included between April 2018 and March 2020. Cancer was diagnosed in 45 patients. 3D ABUS sensitivity was 72.1% (95% CI [57.2–83.4%]), specificity 84.4% (95% CI [80.8–87.4%]), PPV 29.2% (95% CI [21.4–38.5%]), and NPV 97.1% 95.0–98.4%). Sensitivity of DBT plus HHUS was 100% (95% CI [90.2–100%]), specificity 71.4% (95% CI [67.2–75.2%]), PPV 23.8% (95% CI [18.1–30.5%]) and NPV 100% (95% CI [98.7–100%]). Twelve out of 43 (27.9%) malignancies in BI-RADS 0 lesions were missed on 3D ABUS, despite being detected on DBT and/or HHUS. Supplemental 3D ABUS resulted in the detection of 57 new lesions and six extra biopsy procedures, all were benign. Conclusion 3D ABUS in the diagnostic work-up of BI-RADS 0 recalls may miss over a quarter of cancers detected with HHUS and/or DBT and should not be used to omit biopsy. Supplemental 3D ABUS increases the benign biopsy rate. Trial registration Dutch Trial Register, available via https://www.onderzoekmetmensen.nl/en/trial/29659 Critical relevance statement Supplemental 3D automated breast ultrasound in the work-up of BI-RADS 0 recalls may miss over a quarter of cancers detected with other methods and should not be used to omit biopsy; ABUS findings did increase benign biopsy rate. Key Points Automated breast ultrasound (ABUS) may miss over 25% of cancers detectable by alternative methods. Don’t rely solely on 3D ABUS to assess indication for biopsy. New findings with supplemental 3D ABUS increase the benign biopsy rate. Graphical Abstract
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