Performance of AI-Based software in predicting malignancy risk in breast lesions identified on targeted ultrasound.

Introduction: Targeted ultrasound is commonly used to identify lesions characterized on magnetic resonance imaging (MRI) that were not recognized on initial mammography or ultrasound and is especially valuable for guiding percutaneous biopsies. Although artificial intelligence (AI) algorithms have been used to differentiate benign from malignant breast lesions on ultrasound, their application in classifying lesions on targeted ultrasound has not yet been studied.

Objective: To evaluate the performance of AI-based software in predicting malignancy risk in breast lesions identified on targeted ultrasound.

Methods: This was a retrospective, cross-sectional, single-center study that included patients with breast lesions identified on MRI who underwent targeted ultrasound and percutaneous ultrasound-guided biopsy. The ultrasound findings were analyzed using AI-based software and subsequently correlated with the pathological results.

Results: 334 lesions were evaluated, including 183 mass and 151 non-mass lesions. On histological analysis, there were 257 (76.9 %) benign lesions, and 77 (23.1 %) malignant. Both the AI software and radiologists demonstrated high sensitivity in predicting the malignancy risk of the lesions. The specificity was higher when evaluated by the radiologist using the AI software compared to the radiologist's evaluation alone (p < 0.001). All lesions classified as BI-RADS 2 or 3 on targeted ultrasound by the radiologist or the AI software (n = 72; 21.6 %) showed benign pathology results.

Conclusion: The AI software, when integrated into the radiologist's evaluation, demonstrated high diagnostic accuracy and improved specificity for both mass and non-mass lesions on targeted ultrasound, supporting more accurate biopsy decisions and potentially reducing false positives without missing cancers.