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NCT06934239 · ClinicalTrials.gov registry record · Phase 4
A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
A Phase 4 study of Breast Cancer Screening and Artificial Intelligence (AI), sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 400,000
- Enrollment target
- 6
- Study locations
NCT06934239 is a Phase 4 study of Breast Cancer Screening and Artificial Intelligence (AI) that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 400,000 participants, above the 13,442-participant average among 8 other Breast Cancer Screening trials with a reported enrollment target (2876% higher). The trial reports 6 study locations across 5 states.
The verdict
NCT06934239, a Phase 4 study of Breast Cancer Screening and Artificial Intelligence (AI), is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 400,000 participants
- Enrollment target
- 6
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Artificial intelligence (AI) decision-support tool
Study Locations (6)
California
- University of California Los Angeles Health System - Los Angeles
- University of California, San Diego - San Diego
Florida
- University of Miami Health System - Miami
Massachusetts
- Boston Medical Center - Boston
Washington
- University of Washington Health System - Seattle
Wisconsin
- University of Wisconsin-Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400,000 participants |
| Start Date | 2025-10-15 |
| Est. Completion | 2030-03-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06934239
The ClinicalTrials.gov registry entry for NCT06934239 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 400,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 13,442-participant average among 8 other Breast Cancer Screening trials with a reported enrollment target (2876% higher). The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer Screening appearing as the primary indexed condition, and to 1 intervention - of which Artificial intelligence (AI) decision-support tool is the first listed.
NCT06934239 reports 6 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06934239 about?
NCT06934239 is a clinical study titled "A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients". 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 radiolo...
What is the current status of trial NCT06934239?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 400,000 participants. The study started on 2025-10-15. Estimated completion is 2030-03-01.
What conditions does trial NCT06934239 study?
This clinical trial studies the following conditions: Breast Cancer Screening, Artificial Intelligence (AI).
What interventions are being tested in trial NCT06934239?
The interventions under investigation include: Artificial intelligence (AI) decision-support tool (DEVICE).
Who is sponsoring clinical trial NCT06934239?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06934239 being conducted?
This trial has 6 study locations across California, Florida, Massachusetts, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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