Clinical Trial

AI-Enhanced Imaging in Population Breast Cancer Screening

Recruiting
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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.
Trial Details
NCT Number NCT07411443
Lead Sponsor Fudan University
Conditions Breast Cancer Screening
Enrollment 16,000 participants
Start Date 2025-01-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-13