Functional Imaging in the Assessment of mRCC Response to Sunitinib
Pilot Study to Evaluate the Feasibility of Functional MRI in Metastatic Renal Cell Carcinoma (mRCC) With Test--retest Repeatability and Early Response Assessment
研究概览
详细说明
Renal cell carcinoma (RCC) is a highly vascularized tumour that is dependent on new vessel formation (angiogenesis) for growth and spread beyond the kidney (metastases). In recent years a new class of drugs have been developed which target the formation of this blood supply, stopping tumour growth and resulting in increased survival. These anti-angiogenic drugs such as Sunitinib, Pazopanib, Axitinib and Everolimus are now the standard of care in metastatic RCC (mRCC) in the United Kingdom.
Currently we assess if cancers are responding to treatment by looking at changes in the size of the tumour and metastases using computed tomography. However, the positive effects of drugs such as sunitinib do not always show a change in size, particularly early in treatment. Therefore we need to develop alternative methods for assessing if patients are responding in order to optimise individual management plans and prevent unnecessary toxicity and cost.
The aim of this study is to assess if three different functional magnetic resonance imaging (MRI) techniques are able to predict which patients will derive benefit from anti-angiogenic therapy early in their treatment. The study will recruit patients with mRCC who are going to be treated with anti-angiogenic drugs. These patients will have an MRI scan before they commence treatment and then a further scan after one treatment cycle (4 weeks) in addition to their normal clinical follow-up. The sequences being evaluated (arterial spin labeling, diffusion-weighted imaging and dynamic contrast imaging) look at the blood supply to the cancer and it is expected that there will be different changes in this blood supply in patients who are benefiting from treatment compared to those who are not responding. Early knowledge of response will help doctors choose the most appropriate treatment option for each individual patient.
Consenting patients with treatment naïve metastatic clear cell RCC will be recruited to the study. Before commencing anti-angiogenic therapy, patients will undergo 3 Tesla MRI covering the primary tumour or largest metastatic deposit identified from their staging CT examination if prior nephrectomy has been performed. Following 4 weeks of therapy (one treatment cycle), patients will undergo repeat MR imaging using the same protocol.
研究类型
阶段
- 不适用
联系人和位置
学习地点
-
-
-
London、英国
- Imperial College Healthcare NHS Trust
-
-
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
描述
Inclusion Criteria:
- Patients with newly diagnosed (i.e. treatment naive) metastatic clear cell renal cell carcinoma judged by their treating physician to have the potential to derive benefit from anti-angiogenic therapy
- Histopathologically confirmed clear cell renal cell carcinoma
- Male or female aged 18 years or older
Exclusion Criteria:
- Previous medical treatment for renal cancer
- Cardiac pacemaker or other contra-indication to magnetic resonance imaging
- Contra-indication to intravenous Gadolinium
- Pregnancy or breastfeeding
学习计划
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:Metastatic renal cell carcinoma
Patients with clear cell renal cell carcinoma treated with anti-angiogenic therapies
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
To determine if functional MRI techniques are able to detect treatment-related changes in patients with metastatic renal cell carcinoma treated with sunitinib
大体时间:At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
|
At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Repeatability of Arterial Spin Label and Diffusion Weighted MRI parameters
大体时间:At baseline MRI scan
|
At baseline MRI scan
|
Changes in imaging parameters with treatment
大体时间:At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
|
At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
|
Correlation of imaging parameters with progression free survival
大体时间:Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
|
Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
|
Correlation of imaging parameters with overall survival
大体时间:Time from study enrolment to date of death from any cause (up to 36 months)
|
Time from study enrolment to date of death from any cause (up to 36 months)
|
合作者和调查者
调查人员
- 首席研究员:Nishat Bharwani, MRCP FRCR、Imperial College Healthcare NHS Trust
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
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.