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Recruiting NCT07608081

The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnosis and Efficacy Assessment of Breast Cancer

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnosis and Efficacy Assessment of Breast Cancer.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

We consecutively enrolled patients presenting with breast space-occupying lesions at our hospital. Medical imaging data from simultaneously acquired ultrafast DCE-MRI, time-dependent diffusion MRI (TDD-MRI), magnetic resonance elastography (MRE), andvirtual magnetic resonance elastography(vMRE), along with clinical and pathological data, were collected. The study aims to evaluate and explore the clinical application value of these multimodal imaging techniques in the precision diagnosis, treatment, and prognosis of breast cancer. The findings are intended to provide a robust imaging basis for formulating and adjusting more precise, individualized treatment plans and prognostic assessments for patients. Ultimately, this research seeks to improve patient quality of life, optimize the allocation of medical resources, and advance the development of precision medicine.

Interventions

  • Diagnostic test The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnosis and Efficacy Assessment of Breast Cancer
    The MRI scan is part of the standard treatment protocol. Medical imaging data from simultaneously acquired ultrafast DCE-MRI, time-dependent diffusion MRI (TDD-MRI), magnetic resonance elastography (MRE), andvirtual magnetic resonance elastography(vMRE), along with clinical and pathological data, were collected.

Primary outcome measures

  • efficacy evaluation [Time frame: From enrollment to the end of surgery]
  • Differentiation between benign and malignant lesions [Time frame: From enrollment to the end of surgery]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old
  • Female patients with BI-RADS class 4 or above breast lesions detected by mammography or ultrasound
  • Perform breast new technology MRI examination (ultra fast DCE-MRI、OGSE 、MRE、vMRE)within one week before biopsy or surgery

Exclusion criteria

  • Previously received breast radiotherapy, chemotherapy, surgery, or targeted therapy
  • Unable to cooperate in completing MRI examination
  • The image data contains serious artifacts (such as motion artifacts and metal artifacts), making it impossible to measure parameters
  • The lesion cannot be clearly identified and outlined on the image
  • Pregnant and lactating women
  • Combined with severe liver, liver, and kidney diseases, coagulation dysfunction, or other malignant tumors

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Yunnan Cancer Hospital — Kunming

Identifiers

NCT: NCT07608081 · KYLX2025-331

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗