A Randomized Controlled Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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 intelligence (AI) decision-support tool in real-world U.S. settings and to assess patients' and radiologists' perspectives on AI in medicine. The main question it aims to answer is: Does an FDA-cleared AI decision-support tool for digital tomosynthesis (DBT) improve screening outcomes in real world US clinical settings? This trial will include all interpreting radiologists and all adult patients undergoing screening mammography at any of the participating breast imaging facilities across 6 regional health systems (University of California, Los Angeles (UCLA), University of California, San Diego (UCSD), University of Washington-Seattle, University of Wisconsin-Madison, Boston Medical Center, and University of Miami) during the trial period. All screening mammograms at these facilities will be randomized to either intervention (radiologist assisted by an AI decision support tool) versus usual care (radiologist alone) to see if interpreting these mammograms with the AI tool's assistance improves patient screening outcomes. We are targeting 400,000 screening exams across the participating health systems in this trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
University of California Los Angeles Health System
RECRUITING
Los Angeles
University of California, San Diego
RECRUITING
San Diego
Florida
University of Miami Health System
RECRUITING
Miami
Massachusetts
Boston Medical Center
RECRUITING
Boston
Washington
University of Washington Health System
RECRUITING
Seattle
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
Contact Information
Primary
Michelle L'Hommedieu, PhD
mlhommedieu@mednet.ucla.edu
(310) 592-9454
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2030-03-01
Participants
Target number of participants: 400000
Treatments
Active_comparator: Intervention (radiologist assisted by AI)
3D screening exams randomized to this arm will be interpreted by the radiologist assisted by the AI decision-support tool (i.e., intervention).
No_intervention: Standard care (radiologist alone)
3D screening exams randomized to this arm will be interpreted in accordance with standard care (i.e., interpreted by the radiologist alone, without an AI decision-support tool's assistance).
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center
Collaborators: University of Washington, University of California, San Diego, University of Miami, Boston Medical Center, University of Wisconsin, Madison, California Breast Cancer Research Program, University of California, Davis, University of California, Los Angeles, Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov