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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Non-contrast multiparametric breast MRI with AI-based radiomics analysis

    Diagnostic test

    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

    Diagnostic test

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

Treatment groups

30,000 Participants
are divided into 2 treatment groups
Group A: Breast Cancer/Suspected CasesExperimental treatment 1 intervention
Group B: Standard Radiologist ReadingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of AI-based non-contrast multiparametric MRI for breast cancer detection

Diagnostic performance of the AI-based radiomics model using non-contrast multiparametric breast MRI (T2WI, DWI, ADC) will be evaluated. The performance will be compared against the reference standard (histopathology or follow-up imaging).

Time frame
Within 12 months of study enrollment

Secondary outcomes

1

Sensitivity and specificity stratified by breast cancer molecular subtype

Evaluate model performance in subgroups defined by ER, PR, HER2, and Ki-67 status

Time frame
Within 12 months of enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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