Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07411443
NA

AI-Enhanced Imaging in Population Breast Cancer Screening

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

35 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

16000

Start Date

2025-01-01

Completion Date

2027-12-31

Last Updated

2026-02-13

Healthy Volunteers

Yes

Interventions

DEVICE

AI-assisted screening

The intervention group will undergo combined screening using AI-assisted ultrasound plus AI-assisted mammography

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shaghai, China