Impact of Artificial Intelligence on Breast Cancer Screening

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 3D screening mammograms are interpreted with versus without a leading FDA-cleared AI decision-support tool in real-world U.S. settings and to assess patient's perspectives on AI in medicine.

The main questions it aims to answer are:

1. Will AI use be associated with an increase in cancer detection and an initially higher recall rate as radiologists start using AI, followed by a recall rate comparable to that without AI (no more than 1.5 percentage-points higher) after a learning curve period? Will AI use will be associated with lower rates of missed breast cancers and similar rates of false alarms after a learning curve period?

2. Will improved patient outcomes with AI be most pronounced for exams on women who are White, older, and have less dense breasts, and on baseline exams? Will AI aid patient outcomes when the interpretation is by radiologists with less clinical experience, lower annual interpretive volume, and less tolerance of ambiguity? Yet, will there be greater automation bias (the tendency for humans to defer to a computer algorithms' results) noted among these radiologists?

3. What are patients' perspectives on AI in mammography, including their confidence in breast cancer screening when interpreted with vs. without AI? What are patients' perspectives on the importance of the study results?

Researchers will compare patient-centered outcomes when 3D screening mammograms are interpreted with versus without a leading FDA-cleared AI decision-support tool in real-world U.S. settings.

This trial will include all adult patients undergoing 3D mammography breast cancer screening at imaging facilities across University of California at Los Angeles and University of Washington health systems and all radiologists interpreting breast cancer screening. All screening mammograms at these facilities will be randomized to either intervention (radiologist with AI support) versus usual care (radiologist alone) to see if interpreting these mammograms with the AI tool's assistance improves patient outcomes.

Detailed Description

AIM 1. Conduct a 2-year randomized controlled trial (RCT) and assess immediate performance measures and outcomes of the diagnostic evaluation cascade for 3D screening mammograms interpreted with vs. without AI: Outcomes will include recall rate, cancer detection rate, and positive predictive value (PPV1), along with measures of the diagnostic evaluation cascade including short-interval follow-up rate, biopsy rate, and biopsy yield (i.e., PPV2 and PPV3).

AIM 2: Assess 1-year breast cancer performance measures and clinical patient outcomes for 3D screening mammograms interpreted with vs. without AI: After linkage with state and regional tumor registries, we will compare longer-term performance measures (sensitivity, specificity, false positive rates) and patient outcomes (interval cancer rates and tumor molecular subtypes) associated with screening with vs. without AI.

AIM 3: We will perform subgroup analyses of the interaction of patient-, exam-, and radiologist-level characteristics associated with improved screening performance with AI. Patient characteristics will include demographics (e.g., age, race/ethnicity) and risk factors (e.g., breast density, family history of breast cancer, previous breast biopsy, prior breast cancer). Exam-level factors will include baseline vs. subsequent screening exams and mammography unit manufacturer. Radiologist characteristics will include experience level (e.g., general clinical experience and experience with AI), tolerance of ambiguity in clinical decision-making and trust in AI, measured with standardized survey tools.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-18
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Study Start: 2025-09-01
• Primary Completion: 2030-02-01
• Study Completion: 2031-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 154474

Inclusion Criteria

• Be an adult patient undergoing 3D mammography breast cancer screening at any of the 16 imaging facilities across UCLA and UW health systems

OR

• Be a radiologist interpreting breast cancer screening at one of these imaging facilities

Exclusion Criteria

• Is neither an adult patient undergoing 3D mammography breast cancer screening at any of the 16 imaging facilities across UCLA and UW health systems

NOR

• Is a radiologist interpreting breast cancer screening at one of these imaging facilities

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	Day of interpretation	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
Missed breast 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), yet breast cancer is diagnosed within 1 year, per 1,000 screening exams
False alarm (FA) recall	No cancer diagnosed within 365 days of study entry screening mammogram	Proportion of screening exams recalled for additional imaging with no breast cancer diagnosed within 1 year
False alarm (FA) short-interval follow-up (SIFU)	No cancer diagnosed within 365 days of study entry screening mammogram	Proportion of screening exams recalled for short-interval follow-up with no breast cancer diagnosed within 1 year
False-alarm (FA) biopsy recommendation	No cancer diagnosed within 365 days of study entry screening mammogram	Proportion of screening exams recalled for breast biopsy 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

Trial Locations

Locations (2)

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

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