RecruitingPhase 4NCT06934239

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

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

Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

400,000 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Screening Artificial Intelligence (AI)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing how well AI-assisted mammography screening finds breast cancer compared to standard mammography screening, to see if AI helps radiologists catch more cancers with fewer false alarms. You may be eligible if: you are 18 years or older; and you are getting a routine breast screening mammogram at one of the participating hospitals, or you are a radiologist who reads mammograms at one of those sites. You may NOT be eligible if: you have opted out of all research at your health system. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEArtificial intelligence (AI) decision-support tool

The intervention is an AI decision-support tool to help radiologists interpret 3D screening mammograms. For exams randomized to this intervention arm, the first image displayed to the radiologist upon opening an exam on the viewing station will be a one-page, standardized AI report showing the overall exam risk (elevated, intermediate, or low), image region markings, lesion scores from 1-100 (100 being the highest suspicion), bounding boxes, and relevant slice locations for 3D exams. Radiologists can toggle markings on/off and retain full control over the final interpretation of the exam as positive or negative (i.e., they can choose to ignore the AI information). Randomization occurs 1:1 at the exam level via automated code at image acquisition. Returning patients in year two will be re-randomized. Radiologists cannot filter their exam lists by AI availability or risk, and randomization will be independently managed at each participating health system.