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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer Screening; Artificial Intelligence (AI)

• Registration Number: NCT06934239
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Detailed Description

During the RCT the AI support tool will be randomized to be turned on or off (1:1) at the mammography exam level. Patients who return for screening exams in year 2 of recruitment will be randomized again (e.g., they will not retain their prior randomization). Radiologists will not be able to sort exams based on AI availability or AI scores. Randomizing by exam level will ensure that we capture a substantial number of interpretations with vs. without AI for each radiologist, allowing for quantification of the radiologist-level AI learning curve. We are not randomizing at the facility level as some radiologists interpret exams acquired at different facilities on the same day. By randomizing AI at the exam level, we will have the best ability to estimate and adjust for temporal trends in screening outcomes across individual radiologists. Randomization across large regional health systems will be managed independently at each participating site.

Our RCT randomizes screening mammography exams to be interpreted either with or without an AI decision-support tool. As a result, radiologists cannot be blinded to study arm during screening mammography interpretation. However, interpreting radiologists and facility staff (e.g., those scheduling the exams) will not know in advance which patients will be randomized to the AI tool. Randomization occurs within minutes after the breast imaging acquisition (i.e., when the mammography technologist captures the images) by an automated system that was developed by a third-party AI platform and successfully piloted at UCLA. Thus, the AI data (or lack thereof) is embedded within the mammogram before the radiologist opens the exam, preventing any option to "add AI" to an exam randomized to be interpreted without AI. Radiologists will be aware of AI availability only at the time of interpretation, as AI information will appear upon opening the exam (e.g., the AI information pops up with the exam images).

Study Timeline

• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-18
• Status Verified: 2025-10
• Study Start: 2025-10-01
• Last Update Submitted: 2025-10-03
• Last Update Posted: 2025-10-08
• Primary Completion: 2028-03-01
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cancer detection rate	Cancer diagnosed within 90 days of positive study entry screening mammogram	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
Recall rate	Through study completion, an average of 1 year	Number of screening exams recalled for diagnostic work-up (initial BI-RADS assessment of 0, 3, 4, or 5), per 1,000 screening exams

Secondary Outcome Measures

Name	Time	Method
Interval cancer rate (i.e., false-negative rate)	Cancer diagnosed within 365 days of a negative study entry screening mammogram	Number of screening exams with a negative assessment (final BI-RADS assessment of 1 or 2) and breast cancer diagnosed within 1 year, per 1,000 screening exams
False positive recall rate	No cancer diagnosed within 365 days of a positive study entry screening mammogram	Proportion of screening exams recalled for additional imaging (final BI-RADS assessment of 1, 2, or 3), with no breast cancer diagnosed within 1 year
False positive short-interval follow-up recommendation rate	No cancer diagnosed within 365 days of a positive study entry screening mammogram	Proportion of screening exams recalled for short-interval follow-up (final BI-RADS assessment of 3) with no breast cancer diagnosed within 1 year
False positive biopsy recommendation rate	No cancer diagnosed within 365 days of a positive study entry screening mammogram	Proportion of screening exams recalled for breast biopsy (final BI-RADS assessment of 4 or 5) with no breast cancer diagnosed within 1 year
Trust and confidence in AI	Years 1,2 and Years 4,5	Trust and confidence in AI gathered from focus group and survey data
Efficiency metrics (only for the UCLA site)	Through study completion, an average of 1 year	Interpretation time required for radiologists to interpret each mammogram with versus without AI.; Delivery time, using time stamp data from exam acquisition to delivery of results to patients (aka turnaround time).

Trial Locations

Locations (6)

University of California, San Diego; 🇺🇸 San Diego, California, United States

University of Miami Health System; 🇺🇸 Miami, Florida, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States

University of California Los Angeles Health System; 🇺🇸 Los Angeles, California, United States

University of Washington Health System; 🇺🇸 Seattle, Washington, United States