Clinical trial Recruiting at 1 site Interventional Ages 35 to 69 Women only

AI-enhanced breast imaging for population screening

Official title: Population-based Breast Cancer Screening Study Using AI-Assisted Imaging Technology

Run by Fudan University · NCT07411443 · Data updated 2026-11-12

This project will test whether combining AI-assisted breast ultrasound and AI-assisted mammography improves detection accuracy and efficiency for women aged 35–69 in population-based breast cancer screening.

Quick facts

Study typeInterventional
Ages35 Years to 69 Years
SexWomen only
Enrollment16000 (estimated)
SponsorFudan University
Academic / other
Locations1 site (Shanghai, Shaghai)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedFebruary 13, 2026
Trial IDNCT07411443 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 35 to 69 who are participating in the Two Cancers (Breast and Cervical Cancer) Screening program and who have no history of breast cancer or other cancers in the past five years are eligible.

Probably not a fit

People with serious cardiopulmonary, liver, or kidney insufficiency, other severe systemic disease, or a life expectancy under five years are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, district-based cluster-controlled screening trial comparing combined AI-assisted ultrasound plus AI-assisted mammography to conventional screening (initial ultrasound followed by mammography). Districts will be grouped as clusters and assigned to the intervention or control arm, and eligible women will receive screening according to their cluster assignment. The trial will measure diagnostic accuracy, workflow efficiency, and feasibility for large-scale population screening. Screenings will be conducted at participating local centers, with coordination through Fudan University Shanghai Cancer Center.

Why it matters

Potential benefit: If successful, combining AI-assisted imaging could increase early cancer detection, reduce false positives, and make large-scale screening faster and more feasible.

How similar studies have gone: Smaller studies of AI-assisted mammography and ultrasound have shown promising improvements in accuracy and efficiency, but large population-based cluster-controlled trials remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* women aged 35 to 69 years, who were attending the "Two Cancers (Breast and Cervical Cancer) Screening" project, and had no history of breast cancer, including in-situ cancer, or any other cancers in the previous five years.

Exclusion Criteria:

* have serious cardiopulmonary insufficiency, liver or kidney insufficiency, or other systemic diseases, and a life expectancy of less than five years

Where it's running

  • Fudan University Shanghai Cancer Center
    Shanghai, Shaghai, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.