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NCT07205276
NA

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

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Standard radiologist reading of non-contrast multiparametric breast MRI

Imaging data interpreted by trained radiologists following routine clinical practice, without AI assistance.