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RecruitingAccepts healthy volunteersPhase 4

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

Jonsson Comprehensive Cancer Center · with University of California, Los Angeles, University of California, San Diego · NCT06934239

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
400000
US sites recruiting
6
Study start
October 15, 2025
Record last updated
November 26, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Artificial intelligence (AI) decision-support tool

Conditions: Breast Cancer Screening; Artificial Intelligence (AI)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

  • 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.

Exclusion Criteria

  • Patients who have opted out of all research at the health system

Recruiting US locations

  • University of California Los Angeles Health System

    Los Angeles, CA 90024

    Site contact: Michelle L'Hommedieu, PhD · (310) 592-9454 · mlhommedieu@mednet.ucla.edu

  • University of California, San Diego

    San Diego, CA 92093

    Site contact: Haydee Ojeda-Fournier, MD · (858) 442-1902 · hojeda@health.ucsd.edu

  • University of Miami Health System

    Miami, FL 33136

    Site contact: Jose Net, MD · (305) 215-0461 · jnet@med.miami.edu

  • Boston Medical Center

    Boston, MA 02118

    Site contact: Clare Poynton, MD, PhD · (617) 638-6626 · clare.poynton@bmc.org

  • University of Washington Health System

    Seattle, WA 98195

    Site contact: Janie Lee, MD, MSc · (206) 606-6241 · jmlee58@fredhutch.org

  • University of Wisconsin-Madison

    Madison, WI 53706

    Site contact: Christoph Lee, MD, MSc · (608) 263-9377 · cilee3@uwhealth.org

Study contacts (from the official record)

  • Michelle L'Hommedieu, PhD · (310) 592-9454 · mlhommedieu@mednet.ucla.edu
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A Trial Comparing Screening Mammography With and Without… (NCT06934239) | Bored Studies