MR Characterisation/Localisation of Breast Cancer
Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer
Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in detecting, localising and characterising satellite lesions in relation to an index breast tumour in order to improve definition of clinical target volume after local excision.
Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for localising unsuspected multifocal and multicentric lesions in women diagnosed with early breast cancer.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Surrey
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Sutton、Surrey、英国、SM2 5PT
- Royal Marsden NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Biopsy proven invasive ductal carcinoma of the breast
- Unifocal disease
- Patient proceeding to mastectomy
Exclusion Criteria:
- Multifocal disease
- Previous surgery to ipsilateral breast
- Neoadjuvant chemotherapy
- Ferromagnetic implants
- Claustrophobia
- Cup size DD or greater
学习计划
研究是如何设计的？
设计细节
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 |
|---|---|---|
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Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions
大体时间：4 years
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Sensitivity of the MR technique in detecting histopathologically-identified multifocal/centric pre-invasive/invasive disease will be calculated (with 95% confidence intervals)from positive or negative correlates.
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4 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Closeness of agreement between MR techniques and histopathology in localising satellite lesions relative to the index tumour.
大体时间：4 years
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Distance & distribution of lesions from reference tumour will be plotted and correlated with distances and signal characteristics seen on multifunctional MR. Pre-op MRI volume will be plotted against histopathological dimensions and examined for agreement between the two methods. Paired Wilcoxon signed-rank tests will be used to test for systematic differences between MRI and pathology measurements. |
4 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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