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Non-Contrast Breast MRI Diagnosis and Risk Stratification Using DWI-Generated Synthetic Contrast Enhancement

NCT07598084 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 12000

Last updated 2026-05-20

No results posted yet for this study

Summary

The goal of this observational study is to develop an integrated breast MRI system that uses diffusion-weighted imaging (DWI) to create synthetic contrast-enhanced images. This system aims to diagnose and screen for breast cancer without the need for contrast agents, while using a generated risk score to perform imaging-based triage and risk stratification.

Participants will include people aged 18 and older who require a breast MRI either for evaluation of a suspicious finding or for high-risk screening.

This study seeks to answer two main questions:

* Can synthetic contrast-enhanced images generated from DWI match real contrast-enhanced images in their ability to distinguish benign from malignant breast lesions?
* Can the risk score derived from DWI-based synthetic images enable imaging-level risk stratification, allowing people at lower risk to avoid contrast agent injection? Researchers will compare the quality of synthetic images against real contrast-enhanced images and will recruit radiologists to assess how well these images perform for diagnostic and screening tasks. MRI data from participants undergoing breast MRI will be used to train, validate, and test this integrated system.

Conditions

  • Breast Neoplasms
  • Artificial Intelligence (AI)
  • Magnetic Resonance Imaging (MRI)
  • Diffusion Magnetic Resonance Imaging
  • Deep Learning

Interventions

DIAGNOSTIC_TEST

Non-contrast breast MRI diagnostic model

An integrated AI model capable of generating synthetic contrast-enhanced images and distinguishing between benign and malignant lesions, as well as performing risk stratification

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-12-31
Completion
2027-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07598084 on ClinicalTrials.gov