Actively Recruiting
Population-based Breast Cancer Screening Study Using AI-Assisted Imaging Technology
Led by Fudan University · Updated on 2026-02-13
16000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Artificial Intelligence (AI)-assisted imaging technologies, including AI-assisted breast ultrasound and AI-assisted mammography, in population-based breast cancer screening. The study aims to improve the effectiveness and feasibility of breast cancer screening by addressing key challenges in large-scale screening. This project will provide scientific evidence for the implementation of AI-assisted imaging in breast cancer detection and explore optimized screening strategies for the Chinese population. Participants will be divided into two groups based on district clusters. The intervention group will receive combined screening using AI-assisted ultrasound plus AI-assisted mammography, while the control group will undergo routine screening with initial breast ultrasound followed by mammography if needed. The trial will compare these approaches across various technical and cost-effectiveness aspects using data from population screening practices. During the study, women will be followed for one year after screening to measure outcomes such as the incidence of early-stage breast cancer and the detection rate of suspicious breast lesions, including masses and calcifications. Researchers will monitor these results to assess the impact of AI-assisted screening compared to routine methods. The total participation period will cover enrollment, screening, and a one-year follow-up to ensure comprehensive evaluation.
CONDITIONS
Brief Title
AI-Enhanced Imaging in Population Breast Cancer Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 35 to 69 years
- Attending the "Two Cancers (Breast and Cervical Cancer) Screening" project
- No history of breast cancer, including in-situ cancer, in the past five years
- No history of any other cancers in the past five years
You will not qualify if you...
- Serious cardiopulmonary insufficiency
- Liver or kidney insufficiency
- Other systemic diseases with a life expectancy of less than five years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants undergo AI-assisted imaging screening or routine screening to detect early-stage breast cancer and suspicious breast lesions.
1 to 2 visits depending on screening schedule
Duration - 1 year
Participants are followed for one year after screening to monitor breast cancer incidence and lesion detection outcomes.
Periodic follow-up visits during the year
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shaghai, China, 021
Actively Recruiting
Research Team
Y
Ying Zheng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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