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Life sciences · Phase 4 Trial
ClinicalTrials.gov · November 9, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT06934239). This is a study registration, not published results. Lead sponsor: Jonsson Comprehensive Cancer Center. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 400000 participants (ESTIMATED). Conditions: Breast Cancer Screening, Artificial Intelligence (AI). Interventions: DEVICE: Artificial intelligence (AI) decision-support tool. Primary outcome measures: Cancer detection rate , Cancer diagnosed within 90 days of positive study entry screening mammogram; Recall rate , Through study completion, an average of 1 year. Brief summary: The goal of this clinical trial is to compare patient-centered outcomes when screening digital breast tomosynthesis (DBT) exams are interpreted with versus without a leading FDA-cleared artificial intelligence (AI) decision-support tool in real-world U.S. settings and to assess patients' and radiologists' perspectives on AI in medicine. The main question it aims to answer is: Does an FDA-cleared AI decision-support tool for digital tomosynthesis (DBT) improve screening outcomes in real world US clinical settings? This trial will include all interpreting radiologists and all adult patients undergoing screening mammography at any of the participating breast imaging facilities across 6 regional health systems (University of California, Los Angeles (UCLA), University of California, San Diego (UCSD), University of Washington-Seattle, University of Wisconsin-Madison, Boston Medical Center, and University of Miami) during the trial period. All screening mammograms at these facilities will be randomized to either intervention (radiologist assisted by an AI decision support tool) versus usual care (radiologist alone) to see if interpreting these mammograms with the AI tool's assistance improves patient screening outcomes. We are targeting 400,000 screening exams across the participating health systems in this trial.