Actively Recruiting

Phase Not Applicable
Age: 35Years - 69Years
FEMALE
Healthy Volunteers
NCT07411443

AI-Enhanced Imaging in Population Breast Cancer Screening

Led by Fudan University · Updated on 2026-02-13

16000

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

AI-Enhanced Imaging in Population Breast Cancer Screening

Who Can Participate

Age: 35Years - 69Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 35 to 69 years
  • Attending the "Two Cancers (Breast and Cervical Cancer) Screening" project
  • No history of breast cancer, including in-situ cancer
  • No diagnosis of any other cancers in the past five years
Not Eligible

You will not qualify if you...

  • Serious cardiopulmonary insufficiency
  • Liver or kidney insufficiency
  • Other systemic diseases with a life expectancy of less than five years

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shaghai, China, 021

Actively Recruiting

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Research Team

Y

Ying Zheng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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