Actively Recruiting

Phase Not Applicable
Age: 35Years - 69Years
FEMALE
Healthy Volunteers
ID07411443

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

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

16000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Artificial Intelligence (AI)-assisted imaging technologies, including AI-assisted breast ultrasound and AI-assisted mammography, in population-based breast cancer screening. The study aims to improve the effectiveness and feasibility of breast cancer screening by addressing key challenges in large-scale screening. This project will provide scientific evidence for the implementation of AI-assisted imaging in breast cancer detection and explore optimized screening strategies for the Chinese population. Participants will be divided into two groups based on district clusters. The intervention group will receive combined screening using AI-assisted ultrasound plus AI-assisted mammography, while the control group will undergo routine screening with initial breast ultrasound followed by mammography if needed. The trial will compare these approaches across various technical and cost-effectiveness aspects using data from population screening practices. During the study, women will be followed for one year after screening to measure outcomes such as the incidence of early-stage breast cancer and the detection rate of suspicious breast lesions, including masses and calcifications. Researchers will monitor these results to assess the impact of AI-assisted screening compared to routine methods. The total participation period will cover enrollment, screening, and a one-year follow-up to ensure comprehensive evaluation.

CONDITIONS

Brief 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, in the past five years
  • No history 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

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - 1 year

Participants undergo AI-assisted imaging screening or routine screening to detect early-stage breast cancer and suspicious breast lesions.

1 to 2 visits depending on screening schedule

Long-term Monitoring

Duration - 1 year

Participants are followed for one year after screening to monitor breast cancer incidence and lesion detection outcomes.

Periodic follow-up visits during the year

Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shaghai, China, 021

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Research Team

Y

Ying Zheng

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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