Experimental: Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast
Experimental: Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast: Breast MRI scan outside of standard treatment options
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Differentiation between benign and malignant lesions — 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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