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AI-Based Self-Supervised Learning Model Using Non-Contrast Breast MRI for Early Screening and Clinical Utility Evaluation
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
Breast cancer is the most common malignant disease among women worldwide, with rising incidence and younger age at onset in China. Early detection is critical for improving survival, yet current screening methods such as mammography and ultrasound show limited sensitivity in Chinese women, particularly those with dense breast tissue. Contrast-enhanced MRI offers higher diagnostic performance but its use is limited by high costs, safety concerns with gadolinium-based contrast agents, and limited accessibility. This investigator-initiated trial aims to evaluate the clinical application of non-contrast multiparametric MRI, combined with advanced artificial intelligence algorithms, for the early detection and diagnosis of breast cancer. The study will collect MRI imaging data from multiple centers and integrate radiomic features across T2-weighted imaging, diffusion-weighted imaging, and apparent diffusion coefficient maps. A deep learning-based model will be developed and validated to improve lesion detection, differential diagnosis, and risk stratification. The ultimate goal of this project is to establish a safe, accurate, and scalable breast cancer screening pathway suitable for Chinese women. By reducing dependence on invasive procedures and contrast agents, and by leveraging AI for standardization and efficiency, this approach may significantly improve early detection rates and contribute to better patient outcomes.
Official title: Construction of an Early Breast Cancer Screening Warning Model Based on Self-supervised Learning With Plain MRI Scans and Prospective Clinical Utility Evaluation
Key Details
Gender
FEMALE
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
30000
Start Date
2025-10-01
Completion Date
2027-12-01
Last Updated
2025-10-03
Healthy Volunteers
No
Interventions
Non-contrast multiparametric breast MRI with AI-based radiomics analysis
Participants will receive standardized non-contrast multiparametric breast MRI scans (T2WI, DWI, ADC). Imaging features will be extracted and analyzed using artificial intelligence-based radiomics and deep learning algorithms to improve early detection and diagnosis of breast cancer.
Standard radiologist reading of non-contrast multiparametric breast MRI
Imaging data interpreted by trained radiologists following routine clinical practice, without AI assistance.