NCT06934239 A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
| NCT ID | NCT06934239 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Breast Cancer Screening |
| Study Type | INTERVENTIONAL |
| Enrollment | 400,000 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400,000 participants in total. It began in 2025-10-15 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Joann G Elmore, MD, MPH
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT06934239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer Screening. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06934239 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06934239 currently recruiting?
Yes, NCT06934239 is actively recruiting participants. Contact the research team at mlhommedieu@mednet.ucla.edu for enrollment information.
Where is the NCT06934239 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Diego, United States, Miami, United States, Boston, United States and 2 additional locations.
Who is sponsoring the NCT06934239 clinical trial?
NCT06934239 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Joann G Elmore, MD, MPH at University of California, Los Angeles. The trial plans to enroll 400,000 participants.
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