Deep learning powered breast ultrasound to improve characterization of breast masses: a prospective study.

BackgroundThe diagnostic performance of ultrasound (US) is heavily reliant on the operator's expertise. Advances in artificial intelligence (AI) have introduced deep learning (DL) tools that detect morphology beyond human perception, providing automated interpretations.PurposeTo evaluate Smart-Detect (S-Detect), a DL tool, for its potential to enhance diagnostic precision and standardize US assessments among radiologists with varying levels of experience.Material and MethodsThis prospective observational study was conducted between May and November 2024. US and S-Detect analyses were performed by a breast imaging fellow. Images were independently analyzed by five radiologists with varying experience in breast imaging (<1 year-15 years). Each radiologist assessed the images twice: without and with S-Detect. ROC analyses compared the diagnostic performance. True downgrades and upgrades were calculated to determine the biopsy reduction with AI assistance. Kappa statistics assessed radiologist agreement before and after incorporating S-Detect.ResultsThis study analyzed 230 breast masses from 216 patients. S-Detect demonstrated high specificity (92.7%), PPV (92.9%), NPV (87.9%), and accuracy (90.4%). It enhanced less experienced radiologists' performance, increasing the sensitivity (85% to 93.33%), specificity (54.5% to 73.64%), and accuracy (70.43% to 83.91%; P <0.001). AUC significantly increased for the less experienced radiologists (0.698 to 0.835 P <0.001), with no significant gains for the expert radiologist. It also reduced variability in assessment between radiologists with an increase in kappa agreement (0.459-0.696) and enabled significant downgrades, reducing unnecessary biopsies.ConclusionThe DL tool improves diagnostic accuracy, bridges the expertise gap, reduces reliance on invasive procedures, and enhances consistency in clinical decisions among radiologists.