Actively Recruiting
A Randomized Controlled Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-11-26
400000
Participants Needed
6
Research Sites
104 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
U
University of California, Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled trial to compare the outcomes of screening mammography exams interpreted with and without the help of an FDA-cleared artificial intelligence (AI) decision-support tool in real-world U.S. settings. The study aims to determine if using AI improves breast cancer detection and recall rates during screening. This trial includes all adult patients undergoing screening mammography and all interpreting radiologists across six regional health systems. During the trial, each 3D screening mammogram will be randomly assigned to either the intervention group, where radiologists receive assistance from the AI decision-support tool, or the usual care group, where radiologists interpret the images alone. Randomization happens at the exam level immediately after image acquisition, and patients returning for screening in the second year will be re-randomized. Radiologists will see AI information only when it is available during interpretation, but they maintain full control over their final diagnosis. Participants will undergo routine screening mammograms, with data collected on cancer detection rates within 90 days and recall rates over about one year. Additional measures include false-positive rates, interval cancer rates, and trust in AI over several years. The study plans to assess these outcomes across approximately 400,000 screening exams, with monitoring done through the participating health systems. Radiologists and patients will contribute perspectives on AI use in medical imaging during the trial period.
CONDITIONS
Brief Title
A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients who have opted out of all research at the health system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening mammography
Duration - Up to 1 year with possible re-randomization for returning participants
Participants undergo 3D screening mammography exams that are randomized to be interpreted either with assistance from an AI decision-support tool or by a radiologist alone without AI support.
1 visit per screening mammogram; participants may have multiple screening visits depending on routine care
Duration - Up to 1 year after each screening mammogram
Participants are monitored for cancer detection and recall outcomes following their screening mammograms, including follow-up for up to 1 year after each mammogram.
Follow-up as part of routine healthcare; no additional study visits required
Trial Site Locations
Total: 6 locations
1
University of California Los Angeles Health System
Los Angeles, California, United States, 90024
Actively Recruiting
2
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
3
University of Miami Health System
Miami, Florida, United States, 33136
Actively Recruiting
4
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
5
University of Washington Health System
Seattle, Washington, United States, 98195
Actively Recruiting
6
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53706
Actively Recruiting
Research Team
M
Michelle L'Hommedieu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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