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NCT06934239
A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Phase 4 trial testing Artificial intelligence (AI) decision-support tool in Breast Cancer Screening in 400,000 participants. Currently enrolling.
1 March 2028
Quick facts
| Lead sponsor | Jonsson Comprehensive Cancer Center |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | screening |
| Enrollment | 400,000 |
| Start date | 15 October 2025 |
| Primary completion | 1 March 2028 |
| Estimated completion | 1 March 2030 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Artificial intelligence (AI) decision-support tool
Conditions studied
- Breast Cancer Screening — all drugs for Breast Cancer Screening →
- Artificial Intelligence (AI) — all drugs for Artificial Intelligence (AI) →
Sponsor
Jonsson Comprehensive Cancer Center — full company profile →
Who can join
18 and older, any sex, with Breast Cancer Screening or Artificial Intelligence (AI). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06934239
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Cancer Screening
Currently open trials in the same condition.
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- NCT07411443 — AI-Enhanced Imaging in Population Breast Cancer Screening · NA · recruiting
- NCT06059300 — Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program · NA · active not recruiting
Other Jonsson Comprehensive Cancer Center trials
Trials by the same sponsor.
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- NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
- NCT07517211 — A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, · not yet recruiting
- NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
- NCT07468903 — Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06934239 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center
- Last refreshed: 26 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06934239.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing