Artificial Intelligence in BI-RADS Categorization of Breast Lesions on Ultrasound: Can We Omit Excessive Follow-ups and Biopsies?

Rationale and objectives: Artificial intelligence (AI) systems have been increasingly applied to breast ultrasonography. They are expected to decrease the workload of radiologists and to improve diagnostic accuracy. The aim of this study is to evaluate the performance of an AI system for the BI-RADS category assessment in breast masses detected on breast ultrasound. MATERIALS AND METHODS: A total of 715 masses detected in 530 patients were analyzed. Three breast imaging centers of the same institution and nine breast radiologists participated in this study. Ultrasound was performed by one radiologist who obtained two orthogonal views of each detected lesion. These images were retrospectively reviewed by a second radiologist blinded to the patient's clinical data. A commercial AI system evaluated images. The level of agreement between the AI system and the two radiologists and their diagnostic performance were calculated according to dichotomic BI-RADS category assessment.

Results: This study included 715 breast masses. Of these, 134 (18.75%) were malignant, and 581 (81.25%) were benign. In discriminating benign and probably benign from suspicious lesions, the agreement between AI and the first and second radiologists was moderate statistically. The sensitivity and specificity of radiologist 1, radiologist 2, and AI were calculated as 98.51% and 80.72%, 97.76% and 75.56%, and 98.51% and 65.40%, respectively. For radiologist 1, the positive predictive value (PPV) was 54.10%, the negative predictive value (NPV) was 99.58%, and the accuracy was 84.06%. Radiologist 2 achieved a PPV of 47.99%, NPV of 99.32%, and accuracy of 79.72%. The AI system exhibited a PPV of 39.64%, NPV of 99.48%, and accuracy of 71.61%. Notably, none of the lesions categorized as BI-RADS 2 by AI were malignant, while 2 of the lesions classified as BI-RADS 3 by AI were subsequently confirmed as malignant. By considering AI-assigned BI-RADS 2 as safe, we could potentially avoid 11% (18 out of 163) of benign lesion biopsies and 46.2% (110 out of 238) of follow-ups.

Conclusion: AI proves effective in predicting malignancy. Integrating it into the clinical workflow has the potential to reduce unnecessary biopsies and short-term follow-ups, which, in turn, can contribute to sustainability in healthcare practices.