A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients

"The intervention is an AI decision-support tool to help radiologists interpret 3D screening mammograms. For exams randomized to this intervention arm, the first image displayed to the radiologist upon opening an exam on the viewing station will be a one-page, standardized AI report showing the overall exam risk (elevated, intermediate, or low), image region markings, lesion scores from 1-100 (100 being the highest suspicion), bounding boxes, and relevant slice locations for 3D exams. Radiologists can toggle markings on/off and retain full control over the final interpretation of the exam as positive or negative (i.e., they can choose to ignore the AI information).~Randomization occurs 1:1 at the exam level via automated code at image acquisition. Returning patients in year two will be re-randomized. Radiologists cannot filter their exam lists by AI availability or risk, and randomization will be independently managed at each participating health system."