AI-Based Self-Supervised Learning Model Using Non-Contrast Breast MRI for Early Screening and Clinical Utility Evaluation

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.

NCT Number	NCT07205276
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: Alibaba DAMO Academy
Conditions	Breast Cancer Detection, Early Detection of Cancer, AI (Artificial Intelligence)
Enrollment	30,000 participants
Start Date	2025-10-01
Primary Completion	2027-10-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-10-03