Screening mammograms with or without AI assistance for breast cancer detection
A Randomized Controlled Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
This trial will try using an FDA-cleared AI tool to help radiologists read screening mammograms for adults to see if it finds more cancers and reduces unnecessary callbacks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT06934239 on ClinicalTrials.gov |
What this trial studies
In a multisite, real-world randomized trial, individual screening mammography exams are randomly assigned to be interpreted with the AI decision-support tool turned on or off at the exam level. Randomization occurs automatically shortly after image acquisition so radiologists cannot sort exams by AI availability, and patients returning in year two may be re-randomized. The design captures many interpretations with and without AI for each radiologist, allowing measurement of both population-level effects on cancer detection and recall rates and a radiologist-level learning curve. Participating sites include six regional U.S. health systems and all adult screening mammograms at those facilities during the trial period are included unless a patient has opted out of research.
Who should consider this trial
Good fit: Adults aged 18 or older who receive routine screening mammograms at one of the participating breast imaging facilities (and the radiologists who interpret those exams) are eligible to participate.
Not a fit: People who are getting diagnostic (not screening) mammograms, who are screened outside the participating sites, or who have opted out of research will not be included and therefore will not directly benefit from this trial.
Why it matters
Potential benefit: If successful, the AI tool could help detect more cancers earlier and reduce unnecessary follow-up imaging and recalls.
How similar studies have performed: Prior research and some FDA-cleared AI tools have shown promise for improving cancer detection and altering recall rates, but large multicenter, exam-level randomized trials in real-world U.S. settings remain limited.
Eligibility criteria
Show full inclusion / exclusion 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: 1. Be at least 18 years of age or older 2. 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
Where this trial is running
Los Angeles, California and 5 other locations
- University of California Los Angeles Health System — Los Angeles, California, United States (Recruiting)
- University of California, San Diego — San Diego, California, United States (Recruiting)
- University of Miami Health System — Miami, Florida, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- University of Washington Health System — Seattle, Washington, United States (Recruiting)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Joann G Elmore, MD, MPH — University of California, Los Angeles
- Study coordinator: Michelle L'Hommedieu, PhD
- Email: mlhommedieu@mednet.ucla.edu
- Phone: (310) 592-9454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.