RecruitingNot ApplicableNCT07411443

AI-Enhanced Imaging in Population Breast Cancer Screening

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


Sponsor

Fudan University

Enrollment

16,000 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 35 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether AI-enhanced imaging tools improve the accuracy of breast cancer screening in Chinese women participating in a national two-cancer screening program. You may be eligible if: you are a woman between 35 and 69 years old; you are participating in the national "Two Cancers" breast and cervical cancer screening project; and you have no history of breast cancer (including in situ) or any other cancer in the past 5 years. You may NOT be eligible if: you have serious heart or lung disease, liver or kidney failure, or other major systemic illnesses with a life expectancy of less than 5 years. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAI-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07411443


Related Trials