Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast Cancer

NCT07608068 | Active Not Recruiting

• 1 other identifier: KYLX2025-329
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to prospectively collect breast MRE and vMRE image data, clinical data, and pathological data from female patients due to breast lesions indicated by mammography or ultrasound with BI-RADS category 4 or above. It evaluates the consistency of MRE and vMRE in measuring breast lesions and compares the diagnostic performance of the two methods in distinguishing between benign and malignant breast conditions, with the goal of determining whether vMRE has the potential to replace or supplement MRE. Furthermore, it explores and compares the correlation and diagnostic efficacy of sADC and virtual shear modulus calculated at different b-values with the true shear modulus, aiming to identify and optimize the optimal imaging protocol suitable for breast imaging. It also investigates the correlation between quantitative parameters of vMRE and MRE and pathological results such as patient pathological grading and molecular typing, providing imaging evidence for individualized precision assessment.

Conditions

Breast Cancer; Breast - Female

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Pathological TNM staging

  From enrollment to the end of surgery

• Consistency Between MRE and vMRE in Lesion Measurement and Comparison of Diagnostic Performance

  From enrollment to the end of surgery

• Correlation of b-value-derived sADC and Virtual Shear Modulus with Reference Parameters, and Optimization of Imaging Protocol

  From enrollment to the end of surgery

Study Arms (1)

Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast

EXPERIMENTAL

This study aims to prospectively collect breast MRE and vMRE image data, clinical data, and pathological data from female patients due to breast lesions indicated by mammography or ultrasound with BI-RADS category 4 or above. It evaluates the consistency of MRE and vMRE in measuring breast lesions and compares the diagnostic performance of the two methods in distinguishing between benign and malignant breast conditions, with the goal of determining whether vMRE has the potential to replace or supplement MRE. Furthermore, it explores and compares the correlation and diagnostic efficacy of sADC and virtual shear modulus calculated at different b-values with the true shear modulus, aiming to identify and optimize the optimal imaging protocol suitable for breast imaging. It also investigates the correlation between quantitative parameters of vMRE and MRE and pathological results such as patient pathological grading and molecular typing, providing imaging evidence for individualized precis

Diagnostic Test: Experimental: Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast

Interventions

Experimental: Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast DIAGNOSTIC_TEST

Breast MRI scan outside of standard treatment options

Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Female patients with breast lesions BI-RADS category 4 and above on mammography or ultrasound
• Breast MRE and vMRE examinations should be performed within 2 weeks prior to needle biopsy or surgery
• Obtaining definitive pathology via needle biopsy or postoperatively

You may not qualify if:

• Pregnant and lactating women
• Previous history of breast treatment (e.g., surgery, radiotherapy, chemotherapy, or targeted therapy, etc.)
• Inability to cooperate for MRI examination, or presence of severe artifacts (e.g., motion artifacts, metal artifacts) in the imaging data that precludes parameter measurement.
• The lesion cannot be clearly identified or delineated on MRE or vMRE images
• Complicated by severe cardiac, hepatic, or renal diseases, coagulation disorders, or other malignancies.

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lianhua Ye

  Ethics Committee of Yunnan Provincial Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 27, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CN (1)