AI-Enhanced Imaging in Population Breast Cancer Screening

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Screening
• Intervention / Treatment: Device: AI-assisted screening

• Study Type: Interventional
• Enrollment (Estimated): 16000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Zheng; Phone Number: 862164175590; Email: j_shen@fudan.edu.cn

Study Locations

• China
  • Shaghai
    • Shanghai, Shaghai, China, 021
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Ying Zheng; Phone Number: 862164172290; Email: zhengying@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• have serious cardiopulmonary insufficiency, liver or kidney insufficiency, or other systemic diseases, and a life expectancy of less than five years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-assisted screening	Device: AI-assisted screening; The intervention group will undergo combined screening using AI-assisted ultrasound plus AI-assisted mammography
No Intervention: Routine screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of early-stage breast cancer over a one-year follow-up period, compared between women who underwent AI-assisted screening and those with routine screening	Early-stage breast cancer was defined as cancer confined to the breast (local) or to the breast and regional lymph nodes (locoregional). Specifically, it referred to tumors <2 cm in diameter, with no ipsilateral axillary lymph node involvement and no distant metastasis. According to the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition) and the Chinese Guideline for Breast Cancer Screening and Early Diagnosis and Treatment (2021, Beijing), early-stage breast cancer encompassed stage 0 (including ductal carcinoma in situ and lobular carcinoma in situ), stage I, and stage II.	From enrollment to 1-year after the end of screening
The detection rate of suspicious breast lesions (including masses and calcifications) over a one-year follow-up period, compared between women who underwent AI-assisted ultrasound combined with AI-assisted mammography and those who received routine scree		From enrollment to 1-year after the end of screening

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024AI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No