A Randomized Controlled Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Trial ID: NCT06934239
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE4
Start date: 2025-10-15
Completion date: 2030-03-01
Sponsor: Jonsson Comprehensive Cancer Center
Collaborators: University of California, Los Angeles; University of California, San Diego; University of Wisconsin, Madison; Boston Medical Center; Patient-Centered Outcomes Research Institute; University of Washington; California Breast Cancer Research Program; University of Miami; University of California, Davis
Conditions: Breast Cancer Screening; Artificial Intelligence (AI)
Interventions: Artificial intelligence (AI) decision-support tool
Locations: University of California Los Angeles Health System; University of California, San Diego; University of Miami Health System; Boston Medical Center; University of Washington Health System; University of Wisconsin-Madison
Countries: United States; United States; United States; United States; United States; United States
Enrollment: 400000
Age range: 18 Years - None
Sex: ALL

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 criteria:
This trial will include all radiologists interpreting screening mammography and all adult patients undergoing screening mammography at any of the participating breast imaging facilities across 6 regional health systems (UCLA, UC San Diego, University of Washington-Seattle, University of Wisconsin-Madison, Boston Medical Center, and University of Miami) during the trial period. Individuals must meet the following eligiblity criteria.

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

Outcomes:
Cancer detection rate; Recall rate