NCT07411443 AI-Enhanced Imaging in Population Breast Cancer Screening
| NCT ID | NCT07411443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Breast Cancer Screening |
| Study Type | INTERVENTIONAL |
| Enrollment | 16,000 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Artificial Intelligence (AI)-assisted imaging technologies (including AI-assisted breast ultrasound and AI-assisted mammography) can effectively improve the accuracy and efficiency of breast imaging examinations, but their application in large-scale population-based breast cancer screening remains very limited. This project aims to improve the effectiveness and feasibility of breast cancer screening by addressing the core issues and bottlenecks in population-based breast cancer screening. We will conduct a prospective cluster-controlled screening trial in the general population, with district-based cluster grouping. The intervention group will undergo combined screening using AI-assisted ultrasound plus AI-assisted mammography, while the control group will receive conventional screening: breast ultrasound for initial screening and mammography for secondary screening. Based on population screening practices, we will evaluate the effectiveness of AI-assisted imaging diagnostic technology in various technical aspects of actual screening and perform cost-effectiveness analyses. This study will investigate the application of AI-assisted breast imaging technology in population-based breast cancer screening, providing scientific evidence for the large-scale implementation of AI-assisted imaging technologies. Furthermore, by combining population screening practices with model simulations, we will explore multi-dimensional breast cancer screening strategies to optimize screening approaches and technologies for the Chinese population.
Eligibility 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
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.