Evaluating the Accuracy of Breast Cancer and Molecular Subtype Diagnosis by Ultrasound Image Deep Learning Model.

Breast ultrasound is the first choice for breast tumor diagnosis in China, but the Breast Imaging Reporting and Data System (BI-RADS) categorization routinely used in the clinic often leads to unnecessary biopsy. Radiologists have no ability to predict molecular subtypes with important pathological information that can guide clinical treatment. This retrospective study collected breast ultrasound images from two hospitals and formed training, test and external test sets after strict selection, which included 2,822, 707, and 210 ultrasound images, respectively. An optimized deep learning model (DLM) was constructed with the training set, and the performance was verified in both the test set and the external test set. Diagnostic results were compared with the BI-RADS categorization determined by radiologists. We divided breast cancer into different molecular subtypes according to hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) expression. The ability to predict molecular subtypes using the DLM was confirmed in the test set. In the test set, with pathological results as the gold standard, the accuracy, sensitivity and specificity were 85.6, 98.7, and 63.1%, respectively, according to the BI-RADS categorization. The same set achieved an accuracy, sensitivity, and specificity of 89.7, 91.3, and 86.9%, respectively, when using the DLM. For the test set, the area under the curve (AUC) was 0.96. For the external test set, the AUC was 0.90. The diagnostic accuracy was 92.86% with the DLM in BI-RADS 4a patients. Approximately 70.76% of the cases were judged as benign tumors. Unnecessary biopsy was theoretically reduced by 67.86%. However, the false negative rate was 10.4%. A good prediction effect was shown for the molecular subtypes of breast cancer with the DLM. The AUC were 0.864, 0.811, and 0.837 for the triple-negative subtype, HER2 (+) subtype and HR (+) subtype predictions, respectively. This study showed that the DLM was highly accurate in recognizing breast tumors from ultrasound images. Thus, the DLM can greatly reduce the incidence of unnecessary biopsy, especially for patients with BI-RADS 4a. In addition, the predictive ability of this model for molecular subtypes was satisfactory,which has specific clinical application value.