A Multireader Multicase (MRMC) Receiver Operating Characteristic (ROC) Study Evaluating Noninferiority of Quantitative Transmission (QT) Ultrasound to Digital Breast Tomosynthesis (DBT) on Detection and Recall of Breast Lesions.

ABSTRACT

RATIONALE AND OBJECTIVES: Quantitative transmission (QT) imaging is an emerging volumetric ultrasound modality for women too young for mammography. QT images tissue without overlap seen in mammography, thereby can potentially improve breast mass detection and characterization and noncancer recall. We compared radiologists' interpretation of QT vs digital breast tomosynthesis (DBT) with a multireader multicase observer performance study. MATERIALS AND METHODS: Study subjects received screening DBT and QT scans in HIPAA-compliant, institutional review board-approved prospective case-collection studies at four clinical sites. Twenty-four Mammography Quality Standards Act-qualified radiologists interpreted 177 cases (66 with cancer, atypia, or solid mass and 111 normal or with nonsolid benign abnormality), first QT, then 2 weeks later DBT synthesized 2D-views. Readers reported up to three findings per case and for each finding a recall or no recall decision and confidence of that decision. The study hypothesis was area under receiver operating characteristic curve (AUC) of QT was noninferior to DBT. Sensitivity and specificity were also compared. RESULTS: AUC of QT (0.746 ± 0.028, mean ± SD) was noninferior to DBT (0.700 ± 0.028) for AUC difference margin of -0.05 (P < .05). AUC difference was 0.046 ± 0.028 (95% CI [-0.008, 0.101]). Sensitivity was 70.6 ± 7.2% for QT and 85.2 ± 6.4% for DBT, specificity was 60.1 ± 12.3% vs 37.2 ± 11.0%, and both differences were statistically significant. Of a total of 21 cases of cysts, readers recommended recall, on average, in 1.1 ± 1.4 cases with QT, but not with DBT, and 10.6 ± 2.2 cases with DBT, but not with QT. CONCLUSION: QT can be a potential alternative to mammography for breast cancer screening of women too young to undergo mammography.