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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 35
Maximum Age: 69
Healthy Volunteers: t
View:

• women aged 35 to 69 years, who were attending the Two Cancers (Breast and Cervical Cancer) Screening project, and had no history of breast cancer, including in-situ cancer, or any other cancers in the previous five years.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Ying Zheng
j_shen@fudan.edu.cn
862164175590
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 16000
Treatments
Experimental: AI-assisted screening
No_intervention: Routine screening
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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