Detection of Acid Sphingomyelinase/Ceramide Pathway Activation in Radiotherapy Patients Using Intravoxel Incoherent Motion (IVIM) Diffusion-weighted Magnetic Resonance Imaging and Serum Biomarkers
2016年9月20日 更新者：Memorial Sloan Kettering Cancer Center
The purpose of this study is to find out if special blood tests and imaging scans can help evaluate the effects of the radiation the patient receives as part of standard treatment.
The patient will undergo either stereotactic or conventional radiation treatment as determined by the treating doctor.
Previous evidence suggests that blood flow to tumors is affected by the amount (dose) of radiation that it receives.
This effect may be seen as soon as 1-2 hours after the radiation is given.
This study will evaluate if these changes can be seen and measured by performing a special type of scan called Intravoxel Incoherent Motion (IVIM) diffusion-weighted Magnetic Resonance Imaging (MRI) and a blood test.
IVIM MRI is a research exam which is similar to a standard MRI exam, with only a slight difference in the technical parameters used to acquire the images.
研究概览
地位
撤销
研究类型
介入性
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
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically proven cancer
- Patients deemed clinically appropriate for radiation treatment as part of the standard care provided by their treating physician, and will receive either 24 Gy (one fraction) or 3 Gy x 10 fractions.
- Life expectancy > 6 months
- KPS>60%
- Age ≥ 18 years old.
Exclusion Criteria:
- Pregnant patients
- Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc
- Prior radiotherapy to the site of intended treatment
- Patients with tumor involving brain or spinal cord
- Platelet count <75,000/μl, HgB level <9 g/dl, WBC <3500/μl
- Presence of metastases in the upper thoracic spine (in order to avoid DW- MRI parameter measurement variability due to cardiac motion)
- Lesions <1.5 cm (to assure robust measurements)
- Non-English speaking patients
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 |
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实验性的：MRI with IVIM DW-MRI
Upon enrollment in the study, each patient will undergo a standard pre-treatment evaluation in the Radiation Oncology Clinic.
Imaging will include MRI with IVIM DW-MRI (as a research exam).
MR imaging will begin within 30 minutes (+/- 15 mins) of the completion of single-dose radiation or the first dose for patients treated with a multifractioned regime.
Patients will have corresponding serum samples collected at approximately 1 hour before and 18-24 hours after the first radiation treatment.
If radiation therapy occurs on a Friday, the collection of the serum 18-24 hours post-treatment may still be feasible.
Patients will be treated with radiation therapy according to our standard clinical guidelines using one of several Varian megavoltage linear accelerators with on-board kilovoltage image-guidance capabilities, using established immobilization devices that are specific to the anatomical site treated at MD's discretion.
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For each patient enrolled, 8-10 mL of whole blood will be collected into glass, anti-coagulant-free tubes and allowed to clot 20-30 minutes.
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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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ASMase activity measurement
大体时间：up to 18-24 hours after the first radiation treatment
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For each serum ASMase activity measurement, we will use 3 technical assay replicates.
Each of three replicates will be averaged.
Then the post-treatment activity will be normalized (fraction) against its paired pre-treatment activity.
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up to 18-24 hours after the first radiation treatment
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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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C16 serum ceramide levels
大体时间：1 year
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Total C16 serum ceramide level, expressed as ng of ceramide per mL, will be measured for the pre-RT serum and post-RT serum.
For each patient, the post-RT C16 ceramide level will be expressed as a fraction of the pre-RT levels.
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1 year
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C18 serum ceramide levels
大体时间：1 year
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Total C18 serum ceramide level, expressed as ng of ceramide per mL, will be measured for the pre-RT serum and post-RT serum.
For each patient, the post-RT C18 ceramide level will be expressed as a fraction of the pre-RT levels.
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1 year
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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
- 首席研究员：Hebert A. Vargas, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2015年6月1日
初级完成 (预期的)
2017年6月1日
研究注册日期
首次提交
2015年6月4日
首先提交符合 QC 标准的
2015年6月5日
首次发布 (估计)
2015年6月8日
研究记录更新
最后更新发布 (估计)
2016年9月21日
上次提交的符合 QC 标准的更新
2016年9月20日
最后验证
2016年9月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 15-104
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.
MRI with IVIM DW-MRI的临床试验
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)主动，不招人
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)终止
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Hospices Civils de Lyon招聘中
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Providence Health & ServicesOregon Health and Science University完全的
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Institute of Cancer Research, United KingdomRoyal Marsden NHS Foundation Trust; National Institute for Health Research, United Kingdom完全的
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University Health Network, TorontoPeter Munk Cardiac Centre招聘中