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NOT YET RECRUITING
NCT07809698
NA

CT-AI Breast Cancer Opportunistic Screening Health Examination Study

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This study evaluates the clinical utility of a locked chest CT artificial intelligence model for opportunistic breast cancer screening among women undergoing health examinations. The study includes a retrospective validation phase and a prospective single-arm implementation phase. AI analyzes existing non-contrast chest CT images without additional CT examinations. Clinical physicians make further evaluation decisions based on AI outputs, imaging findings, ultrasound results and clinical information.

Official title: AI-Assisted Opportunistic Breast Cancer Screening Using Non-contrast Chest CT in Women Undergoing Health Examination: A Retrospective Validation and Prospective Single-Arm Interventional Study

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30000

Start Date

2026-09-01

Completion Date

2030-02-28

Last Updated

2026-09-09

Healthy Volunteers

Yes

Interventions

DEVICE

CT-AI-assisted breast cancer screening

A fixed artificial intelligence model is applied to existing non-contrast chest CT images obtained during routine health examinations to identify and localize suspicious breast lesions and generate a breast cancer risk score and risk category. No additional CT examination is performed for study purposes. Participants meeting predefined AI review criteria are evaluated by trained physicians, who review the original CT images together with the AI output and make the final decision regarding whether additional breast evaluation is recommended. The AI system does not independently diagnose breast cancer or automatically recall participants. Subsequent imaging, biopsy, or treatment is determined according to routine clinical practice and participant preference.