AI-enhanced breast imaging for population screening
Population-based Breast Cancer Screening Study Using AI-Assisted Imaging Technology
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16000 (estimated) |
| Ages | 35 Years to 69 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shaghai) |
| Trial ID | NCT07411443 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shaghai
- Fudan University Shanghai Cancer Center — Shanghai, Shaghai, China (Recruiting)
Study contacts
- Study coordinator: Ying Zheng
- Email: j_shen@fudan.edu.cn
- Phone: 862164175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.