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
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.
Inclusion 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 Criteria:
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