Status:
RECRUITING
A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
University of California, Los Angeles
University of California, San Diego
Conditions:
Breast Cancer Screening
Artificial Intelligence (AI)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 int...
Detailed Description
During the RCT the AI support tool will be randomized to be turned on or off (1:1) at the mammography exam level. Patients who return for screening exams in year 2 of recruitment will be randomized ag...
Eligibility Criteria
Inclusion
- This trial will include all radiologists interpreting screening mammography and all adult patients undergoing screening mammography at any of the participating breast imaging facilities across 6 regional health systems (UCLA, UC San Diego, University of Washington-Seattle, University of Wisconsin-Madison, Boston Medical Center, and University of Miami) during the trial period. Individuals must meet the following eligiblity criteria.
- Be at least 18 years of age or older
- Receive a screening mammogram at one of the participating breast imaging facilities OR be a radiologist who interprets screening mammograms at one of the participating breast imaging facilities.
Exclusion
- 1\. Patients who have opted out of all research at the health system
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
400000 Patients enrolled
Trial Details
Trial ID
NCT06934239
Start Date
October 15 2025
End Date
March 1 2030
Last Update
November 26 2025
Active Locations (6)
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1
University of California Los Angeles Health System
Los Angeles, California, United States, 90024
2
University of California, San Diego
San Diego, California, United States, 92093
3
University of Miami Health System
Miami, Florida, United States, 33136
4
Boston Medical Center
Boston, Massachusetts, United States, 02118