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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 1, 2025 to Oct 15, 2025
    • Site details revised at 6 of 6 sites
    v5
  3. Phase: Not applicable to Phase 4v4 Show 10 more changesShow less
    • Enrollment target: 154474 to 400000
    • Primary completion date: Feb 1, 2030 to Mar 1, 2028
    • Start date: Sep 1, 2025 to Oct 1, 2025
    • Study sites: 2 to 6
    • Study completion date: Feb 1, 2031 to Mar 1, 2030
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 95 words
    • Collaborators: 3 to 9
    • Study title expanded, about 14 words
  4. Phase: Phase 4 to Not applicable
    • Primary completion date: May 1, 2027 to Feb 1, 2030
    • Start date: May 1, 2025 to Sep 1, 2025
    • Study completion date: May 1, 2027 to Feb 1, 2031
    v3
  5. Site contacts updated at 1 of 2 sitesv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06934239
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: University of California, Los Angeles, University of California, San Diego, University of Wisconsin, Madison, Boston Medical Center, Patient-Centered Outcomes Research Institute, University of Washington, California Breast Cancer Research Program, University of Miami, University of California, Davis
Conditions
(from sponsor)		 Breast Cancer Screening, Artificial Intelligence (AI)
Enrollment 400,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov