Deep learning radiomics on grayscale ultrasound images assists in diagnosing benign and malignant of BI-RADS 4 lesions.

This study aimed to explore a deep learning radiomics (DLR) model based on grayscale ultrasound images to assist radiologists in distinguishing between benign breast lesions (BBL) and malignant breast lesions (MBL). A total of 382 patients with breast lesions were included, comprising 183 benign lesions and 199 malignant lesions that were collected and confirmed through clinical pathology or biopsy. The enrolled patients were randomly allocated into two groups: a training cohort and an independent test cohort, maintaining a ratio of 7:3.We created a model called CLDLR that utilizes clinical parameters and DLR to diagnose both BBL and MBL through grayscale ultrasound images. In order to assess the practicality of the CLDLR model, two rounds of evaluations were conducted by radiologists. The CLDLR model demonstrates the highest diagnostic performance in predicting benign and malignant BI-RADS 4 lesions, with areas under the receiver operating characteristic curve (AUC) of 0.988 (95% confidence interval : 0.949, 0.985) in the training cohort and 0.888 (95% confidence interval : 0.829, 0.947) in the testing cohort.The CLDLR model outperformed the diagnoses made by the three radiologists in the initial assessment of the testing cohorts. By utilizing AI scores from the CLDLR model and heatmaps from the DLR model, the diagnostic performance of all radiologists was further enhanced in the testing cohorts. Our study presents a noninvasive imaging biomarker for the prediction of benign and malignant BI-RADS 4 lesions. By comparing the results from two rounds of assessment, our AI-assisted diagnostic tool demonstrates practical value for radiologists with varying levels of experience.