Optoacoustic Imaging With Decision Support for Differentiation of Benign and Malignant Breast Masses: A 15-Reader Retrospective Study

BACKGROUND. Overlap in ultrasound features of benign and malignant breast masses yields high rates of false-positive interpretations and benign biopsy results. Optoacoustic imaging is an ultrasound-based functional imaging technique that can increase specificity. OBJECTIVE. The purpose of this study was to compare specificity at fixed sensitivity of ultrasound images alone and of fused ultrasound and optoacoustic images evaluated with machine learning–based decision support tool (DST) assistance. METHODS. This retrospective Reader-02 study included 480 patients (mean age, 49.9 years) with 480 breast masses (180 malignant, 300 benign) that had been classified as BI-RADS category 3–5 on the basis of conventional gray-scale ultrasound findings. The patients were selected by stratified random sampling from the earlier prospective 16-site Pioneer-01 study. For that study, masses were further evaluated by ultrasound alone followed by fused ultrasound and optoacoustic imaging between December 2012 and September 2015. For the current study, 15 readers independently reviewed the previously acquired images after training in optoacoustic imaging interpretation. Readers first assigned probability of malignancy (POM) on the basis of clinical history, mammographic findings, and conventional ultrasound findings. Readers then evaluated fused ultrasound and optoacoustic images, assigned scores for ultrasound and optoacoustic imaging features, and viewed a POM prediction score derived by a machine learning–based DST before issuing final POM. Individual and mean specificities at fixed sensitivity of 98% and partial AUC (pAUC) (95–100% sensitivity) were calculated. RESULTS. Averaged across all readers, specificity at fixed sensitivity of 98% was significantly higher for fused ultrasound and optoacoustic imaging with DST assistance than for ultrasound alone (47.2% vs 38.2%; p = .03). Across all readers, pAUC was higher (p < .001) for fused ultrasound and optoacoustic imaging with DST assistance (0.024 [95% CI, 0.023–0.026]) than for ultrasound alone (0.021 [95% CI, 0.019–0.022]). Better performance using fused ultrasound and optoacoustic imaging with DST assistance than using ultrasound alone was observed for 14 of 15 readers for specificity at fixed sensitivity and for 15 of 15 readers for pAUC. CONCLUSION. Fused ultrasound and optoacoustic imaging with DST assistance had significantly higher specificity at fixed sensitivity than did conventional ultrasound alone. CLINICAL IMPACT. Optoacoustic imaging, integrated with reader training and DST assistance, may help reduce the frequency of biopsy of benign breast masses.