Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast Cancer
2026年5月19日 更新者：Yunnan Cancer Hospital
Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast Cancer: A Prospective Study
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.
研究概览
地位
主动，不招人
研究类型
介入性
注册 (估计的)
238
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Yunnan
-
Kunming、Yunnan、中国
- Yunnan Cancer Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Performance of Diffusion-weighted Imaging-based Virtual MR Elastography (vMRE) for Diagnosing Breast
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
|
Breast MRI scan outside of standard treatment options
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Differentiation between benign and malignant lesions
大体时间：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
|
From enrollment to the end of surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pathological TNM staging
大体时间：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
|
From enrollment to the end of surgery
|
|
Consistency Between MRE and vMRE in Lesion Measurement and Comparison of Diagnostic Performance
大体时间：From enrollment to the end of surgery
|
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
大体时间：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)
|
From enrollment to the end of surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Lianhua Ye、Ethics Committee of Yunnan Provincial Cancer Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年10月1日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年5月1日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月27日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月19日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.