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Diagnostic Evaluation of Recalled Noncalcified Lesions Using Ultrasound Alone Versus Ultrasound Plus Additional Mammographic Views: A Prospective Study.

Background: The diagnostic performance of digital breast tomosynthesis (DBT) has been shown to be equal to diagnostic mammography. However, the value of additional mammographic views in diagnostic evaluations remains unclear. Objective: The purpose of this study was to compare the performance of diagnostic breast ultrasound (US) alone to combined US and diagnostic mammography for specific noncalcified recalled abnormalities detected on screening DBT. Methods: This was a prospective HIPAA-compliant, IRB-approved study with a single-arm management strategy. Women recalled for noncalcified lesions from screening DBT underwent initial diagnostic US as part of the study protocol. Additional diagnostic mammography was performed at the radiologist's discretion. Imaging assessment decisions determined by BI-RADS assessments and management recommendations, biopsy outcomes, and follow-up were recorded using case report forms completed the day of the diagnostic evaluation and stored in the electronic medical record. Results: From July 2017 to June 2019, 430 recalled noncalcified lesions in 399 women (mean age, 60 years ± 12 years) were included. US alone was performed on 71.2% (306/430) of lesions, while US with diagnostic mammography was performed on 28.8% (124/430). Of recalled lesions, 93.7% of masses (178/190), 60.0% (51/85) focal asymmetries, 46.1% (53/115) asymmetries, 69.2% (9/13) developing asymmetries and 55.6% (15/27) architectural distortions were evaluated with US alone. Of 93 lesions that underwent needle biopsy, 40.9% (38/93) were cancers, all invasive. Thirty-five of 38 cancers (92.1%) were evaluated by US alone, while three (7.9%) were evaluated with US and diagnostic mammography. At median follow-up of 25 months, six cancers were identified (three with US alone and three with US plus diagnostic mammography groups) in patients with initially benign workup. US alone had two false-negative cancers (one architectural distortion identified at follow-up and one mass biopsied stereotactically at initial detection). Conclusion: US alone is effective in the diagnostic evaluation of noncalcified masses recalled on screening tomosynthesis. For asymmetries, diagnostic mammography may be best without the need for additional US, while architectural distortions still warrant diagnostic mammography and US. Clinical Impact: Radiologists should consider performing US first for DBT-recalled noncalcified masses. Omitting diagnostic mammography when US is negative has a low false-negative rate.