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
1 other identifier
interventional
400,000
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2025
Longer than P75 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 18, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
November 26, 2025
October 1, 2025
2.4 years
April 11, 2025
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cancer detection rate
Number of screening exams recommended for breast biopsy (final Breast Imaging- Reporting and Data System \[BI-RADS\] assessment of 4 or 5) resulting in detected cancer, per 1,000 screening exams
Cancer diagnosed within 90 days of positive study entry screening mammogram
Recall rate
Number of screening exams recalled for diagnostic work-up (initial BI-RADS assessment of 0, 3, 4, or 5), per 1,000 screening exams
Through study completion, an average of 1 year
Secondary Outcomes (6)
Interval cancer rate (i.e., false-negative rate)
Cancer diagnosed within 365 days of a negative study entry screening mammogram
False positive recall rate
No cancer diagnosed within 365 days of a positive study entry screening mammogram
False positive short-interval follow-up recommendation rate
No cancer diagnosed within 365 days of a positive study entry screening mammogram
False positive biopsy recommendation rate
No cancer diagnosed within 365 days of a positive study entry screening mammogram
Trust and confidence in AI
Years 1,2 and Years 4,5
- +1 more secondary outcomes
Study Arms (2)
Intervention (radiologist assisted by AI)
ACTIVE COMPARATOR3D screening exams randomized to this arm will be interpreted by the radiologist assisted by the AI decision-support tool (i.e., intervention).
Standard care (radiologist alone)
NO INTERVENTION3D 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- \. Patients who have opted out of all research at the health system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- University of California, Los Angelescollaborator
- University of California, San Diegocollaborator
- University of Wisconsin, Madisoncollaborator
- Boston Medical Centercollaborator
- Patient-Centered Outcomes Research Institutecollaborator
- University of Washingtoncollaborator
- California Breast Cancer Research Programcollaborator
- University of Miamicollaborator
- University of California, Daviscollaborator
Study Sites (6)
University of California Los Angeles Health System
Los Angeles, California, 90024, United States
University of California, San Diego
San Diego, California, 92093, United States
University of Miami Health System
Miami, Florida, 33136, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Washington Health System
Seattle, Washington, 98195, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53706, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Joann G Elmore, MD, MPH
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Diana Miglioretti, PhD
University of California, Davis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 18, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2030
Last Updated
November 26, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
A de-identified dataset from this study will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) housed at the Inter-university Consortium for Political and Social Research (ICPSR) at the University of Michigan, in compliance with PCORI's Policy on Data Management and Data Sharing.