Abstract
BACKGROUND: The detection of masses on mammogram represents one of the earliest signs of a malignant breast cancer. However, masses may be hard to detect due to dense breast tissue, leading to false negative results. In this study, we aimed to explore the clinical application of the convolutional neural network (CNN)-based deep learning (DL) system constructed in our previous work as an objective and accurate tool for breast cancer screening and diagnosis in Asian women. METHODS: This retrospective analysis included 324 patients with masses detected on mammograms at Shenzhen People's Hospital between April and December 2019. (I) Detection: images were independently analyzed by two junior radiologists who were blinded to relative results. Then, a senior radiologist analyzed the images after reviewing all the relevant information as the reference. (II) Classification: masses were classified by the same two junior radiologists and in consensus by two other seniors. Images were also input into the DL system. The sensitivity of detection by junior radiologists and the DL system, effects of different factors [breast density; patient age; morphology, margin, size, breast imaging reporting and data system (BI-RADS) category of the mass] on detection, the accuracy, sensitivity, and specificity of classification, and the area under the receiver operating characteristic (ROC) curve (AUC), were evaluated. RESULTS: A total of 618 masses were detected. The detection sensitivity of the two junior radiologists [78.0% (482/618) and 84.0% (519/618), respectively] was lower than that of the DL system [86.2% (533/618)]. Breast density significantly affected the detection by two junior radiologists (both P=0.030), but not by the DL system (P=0.385). The AUC for classifying masses as negative (BI-RADS 1, 2, 3) or positive (BI-RADS 4A, 4B, 4C, 5) for the DL system was significantly higher compared to those of the two junior radiologists, but not significantly different compared to seniors [DL system, 0.697; junior, 0.612 and 0.620 (P=0.021, 0.019); senior in consensus, 0.748 (P=0.071)]. CONCLUSIONS: The CNN-based DL system could assist junior radiologists in improving mass detection and is not affected by breast density. This DL system may have clinical utility in women with dense breasts, including reducing the impact caused by inexperienced radiologists and the potential for missed diagnoses.