About this trial
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.
Eligibility criteria
Qualifiers
Female, age 30-70 years
Completed breast MRI scan, including at least T2WI, DWI, and ADC sequences
Multimodal data acquired within the same time window (≤90 days)
A clear clinical outcome: pathologically confirmed or ≥12-24 months of negative follow-up
Disqualifiers
Absolute contraindications to MRI (pacemaker, cochlear implant, ocular metal foreign body, etc.)
Pregnant or lactating women
Recent history of breast surgery/radiotherapy (≤6 months) or imaging after neoadjuvant therapy
Substandard image quality (severe motion artifact, signal-to-noise ratio below threshold)
Trial design
Treatments tested in this trial
- Non-contrast multiparametric breast MRI with AI-based radiomics analysis
- Standard radiologist reading of non-contrast multiparametric breast MRI
Treatment groups
Locations
Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Alibaba DAMO Academy
Collaborator