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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast | Diagnostic Test | Breast MRI scan outside of standard treatment options |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of surgery |
| Consistency Between MRE and vMRE in Lesion Measurement and Comparison of Diagnostic Performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lianhua Ye | Ethics Committee of Yunnan Provincial Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunnan Cancer Hospital | Kunming | Yunnan | China |
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Intraclass correlation coefficient (ICC); Bland-Altman analysis etc. |
| 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) | From enrollment to the end of surgery |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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