NCT07411443

AI-Enhanced Imaging in Population Breast Cancer Screening

Population-based Breast Cancer Screening Study Using AI-Assisted Imaging Technology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16,000 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 35 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer Screening

Interventions

Type	Name	Description
DEVICE	AI-assisted screening	The intervention group will undergo combined screening using AI-assisted ultrasound plus AI-assisted mammography

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: China