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NCT Number: NCT07608068

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast - Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yunnan Cancer Hospital

Kunming, Yunnan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Diagnostic Test

Breast MRI scan outside of standard treatment options

Primary outcomes

  1. Differentiation between benign and malignant lesions

    Time frame: From enrollment to the end of surgery

    With puncture biopsy or surgical pathology serving as the gold standard, MRI parameters are used to distinguish benign from malignant lesions

Secondary outcomes

  1. Pathological TNM staging

    Time frame: From enrollment to the end of surgery

    Pathological examination information: The pathology results using surgery/biopsy data are the gold standard, and the depth of tumor invasion, lymph node metastasis, and distant metastasis are recorded

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

    Time frame: From enrollment to the end of surgery

    Intraclass correlation coefficient (ICC); Bland-Altman analysis etc.

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

    Time frame: From enrollment to the end of surgery

    Pearson or Spearman correlation coefficient (between sADC and true real ADC),AUC, sensitivity, specificity, accuracy for each b-value combination,Optimal b-value combination (based on maximal AUC or highest correlation coefficient)

Sponsors and collaborators

Lead sponsor

Yunnan Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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