The diagnostic performance of automated versus handheld breast ultrasound and mammography in symptomatic outpatient women: a multicenter, cross-sectional study in China

Objectives The purpose of this study was to evaluate the diagnostic performance of automated breast ultrasound (ABUS) for breast cancer by comparing it to handheld ultrasound (HHUS) and mammography (MG). Methods A multicenter cross-sectional study was conducted between February 2016 and March 2017 in five tertiary hospitals in China, and 1922 women aged 30–69 years old were recruited. Women aged 30–39 years (group A) underwent ABUS and HHUS, and women aged 40–69 (group B) underwent additional MG. Images were interpreted using the Breast Imaging Reporting and Data System (BI-RADS). All BI-RADS 4 and 5 cases were confirmed pathologically. Sensitivities and specificities of all modalities were compared. Results There were 83 cancers in 677 women in group A and 321 cancers in 1245 women in group B. In the whole study population, the sensitivities of ABUS and HHUS were 92.8% (375/404) and 96.3% (389/404), and the specificities were 93.0% (1411/1518) and 89.6% (1360/1518), respectively. ABUS had a significantly higher specificity to HHUS ( p < 0.01), while HHUS had higher sensitivity ( p = 0.01). In group B, the sensitivities of ABUS, HHUS, and MG were 93.5% (300/321), 96.6% (310/321), and 87.9% (282/321). The specificities were 93.0% (859/924), 89.9% (831/924), and 91.6% (846/924). ABUS had significantly higher sensitivity ( p = 0.02) and comparable specificity compared with MG ( p = 0.14). Conclusion ABUS increased sensitivity and had similar specificity compared with mammography in the diagnosis of breast cancer. Additionally, ABUS has comparable performance to HHUS in women aged 30–69 years old. ABUS or HHUS is a suitable modality for breast cancer diagnosis. Key Points • In breast cancer diagnosis settings, automated breast ultrasound has a higher cancer detection rate, sensitivity, and specificity than mammography, especially in women with dense breasts. • Compared with handheld ultrasound, automated breast ultrasound has higher specificity, lower sensitivity, and comparable diagnostic performance. • Automated breast ultrasound is a suitable modality for breast cancer diagnosis, and may have a potential indication for its further use in the breast cancer early detection.