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

N/AActive Not RecruitingNCT07608068

Yunnan Cancer Hospital238 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

238

Conditions

Breast Cancer Breast - Female

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: From enrollment to the end of surgery

Secondary Outcomes

Pathological TNM staging

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

Time frame: From enrollment to the end of surgery

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

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

Time frame: 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

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)

Time frame: From enrollment to the end of surgery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes