RATIONALE AND OBJECTIVES: To develop and evaluate an AI algorithm that detects breast cancer in MRI scans up to one year before radiologists typically identify it, potentially enhancing early detection in high-risk women. MATERIALS AND METHODS: A convolutional neural network (CNN) AI model, pre-trained on breast MRI data, was fine-tuned using a retrospective dataset of 3029 MRI scans from 910 patients. These contained 115 cancers that were diagnosed within one year of a negative MRI. The model aimed to identify these cancers, with the goal of predicting cancer development up to one year in advance. The network was fine-tuned and tested with 10-fold cross-validation. Mean age of patients was 52 years (range, 18-88 years), with average follow-up of 4.3 years (range 1-12 years). RESULTS: The AI detected cancers one year earlier with an area under the ROC curve of 0.72 (0.67-0.76). Retrospective analysis by a radiologist of the top 10% highest risk MRIs as ranked by the AI could have increased early detection by up to 30%. (35/115, CI:22.2-39.7%, 30% sensitivity). A radiologist identified a visual correlate to biopsy-proven cancers in 83 of prior-year MRIs (83/115, CI: 62.1-79.4%). The AI algorithm identified the anatomic region where cancer would be detected in 66 cases (66/115, CI:47.8-66.5%)
with both agreeing in 54 cases (54/115, CI:%37.5-56.4%). CONCLUSION: This novel AI-aided re-evaluation of "benign" breasts shows promise for improving early breast cancer detection with MRI. As datasets grow and image quality improves, this approach is expected to become even more impactful.