Screening mammograms with or without AI assistance for breast cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.