MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy
2019年5月23日 更新者：University of Michigan Rogel Cancer Center
This study aims to assess changes in vascular permeability in the brain tumor, and in the surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
52
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
-
-
Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Hospital
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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
取样方法
非概率样本
研究人群
Patients with brain metastasis receiving radiotherapy.
描述
Inclusion Criteria:
- Patients with a histological confirmed malignancy and presence of intraparenchymal brain metastases
- Patients are treated by WBRT, SRS, or FSRT
- Age greater than or equal to 18 years
- A life expectancy of greater than or equal to 8 weeks
- Karnofsky performance status (an assessment of general well being and ability to do activities of daily living; scale ranges from 0 to 100 where 100 is perfect health) greater than or equal to 60
- Informed consent with signed study-specific informed consent form
Exclusion Criteria:
- Major medical or psychiatric illness, which, in the investigator's opinion, will prevent completion of the protocol
- Patients with lepto-meningeal metastases documented by Magnetic Resonance Imagine (MRI), Computed Tomography (CT), or Cerebrospinal Fluid (CSF) evaluation
- For patients that will undergo Whole Brain Radiation Therapy (WBRT), previous WBRT is not allowed. Patients who have had brain metastases managed by Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery are eligible
- For patients that will undergo Stereotactic Radiosurgery (SRS), previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a lesion(s) not previously treated.
- For patients that will undergo Fractionated Stereotactic Radiation Therapy (FSRT), previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a lesion(s) not previously treated.
- Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, etc).
- Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the University of Michigan.
- Women who are pregnant are excluded.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Stereotactic Radiosurgery (SRS)
Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series. |
Intervention will not be assigned by the investigator.
Treatment determination will be made prior to study enrollment.
MRI scans will include a routine clinical MRI series.
|
|
Whole Brain Radiation Therapy
Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series. |
MRI scans will include a routine clinical MRI series.
Intervention will not be assigned by the investigator.
Treatment determination will be made prior to study enrollment.
|
|
Stereotactic Radiation Therapy
Patients with brain metastases receiving fractionated (spread out over time) Stereotactic Radiation Therapy (FSRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to FSRT, during the last week of RT but before the last fraction and 1 month after RT. The MRI scan will include a routine clinical MRI series. |
MRI scans will include a routine clinical MRI series.
Intervention will not be assigned by the investigator.
Treatment determination will be made prior to study enrollment.
|
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 |
|---|---|---|
|
Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1
大体时间：Pre-Treatment, 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment
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Fifty metastatic lesions from 21 patients received WBRT and 14 lesions from 9 patients treated by SRS were analyzed.
Permeability of BTB (Blood-Tumor-Barrier) was quantified by the transfer constant, Ktrans, derived from dynamic contrast enhanced (DCE)-MRI that were acquired pre, 1-2 weeks after starting, and 1-month post-radiotherapy.
A percentage volume of the BM with Ktrans >0.005 min-1 (%Vall) was used to evaluate the extent of BTB opening pre-RT and subsequent changes after receiving radiotherapy.
The 50 lesions, from the 21 patients treated with Whole Brain Radiation Therapy, were divided into two subgroups: low-leaky (%Vall <50%) and high-leaky, based upon pre-RT measurements.
Of the 50 lesions, 7 were classified as low leaky and 43 were classified as high leaky.
All 14 SRS lesions were classified as high leaky.
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Pre-Treatment, 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment
|
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Change in Magnitude and Regional Variability of Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB) Permeability (Per Minute) in Tumor, Tumor Margin, Normal Brain and Brain Metastases
大体时间：Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment
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An in-house program, based on a general kinetic model, along with an MRI contrast agent, Gadopentetic Acid (Gd-DTPA), will be used to estimate vascular permeability (per minute).
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Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Mean K^Trans During and After Radiation Therapy
大体时间：Pre-treatment and 1 Month Post Treatment
|
Effect of radiation dose on vascular permeability (per minute) of the Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB).
Permeability of BTB was quantified by Ktrans.
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Pre-treatment and 1 Month Post Treatment
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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：Yue Cao, Ph.D.、University of Michigan Rogel Cancer Center
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
2005年4月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2013年11月13日
首先提交符合 QC 标准的
2014年1月7日
首次发布 (估计)
2014年1月9日
研究记录更新
最后更新发布 (实际的)
2019年7月26日
上次提交的符合 QC 标准的更新
2019年5月23日
最后验证
2019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.