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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnosis and Efficacy Assessment of Breast Cancer

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caiyang Li; Phone Number: +8613658700171; Email: 2020429049@kmmu.edu.cn
• Study Contact Backup: Name: Zhenhui Z Li; Phone Number: +8613698736132; Email: lizhenhui@kmmu.edu.cn

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Recruiting
      • Yunnan Cancer Hospital
      • Contact: Caiyang Li; Phone Number: +8613658700171; Email: 2020429049@kmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnos; Consecutively enrolled patients presenting with breast 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy evaluation	For patients requiring neoadjuvant therapy, after completing the corresponding cycles of neoadjuvant treatment, the patient's surgical pathology results are used as the gold standard to assess tumor regression and determine whether pathological complete response (pCR) has been achieved.	From enrollment to the end of surgery
Differentiation between benign and malignant lesions	With puncture biopsy or surgical pathology serving as the gold standard, MRI parameters are used to distinguish benign from malignant lesions	From enrollment to the end of surgery

Collaborators and Investigators

• Sponsor: Yunnan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography; Elasticity Imaging Techniques
• Other Study ID Numbers: KYLX2025-331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No