AI-Enhanced Imaging in Population Breast Cancer Screening
Recruiting · NCT07411443 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, Shaghai, China