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Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

2018年7月18日 更新者:University of Colorado, Denver

Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma

This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery.

Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery.

This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor.

For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.

研究概览

详细说明

Extent of surgical resection of malignant high grade glioma has been established as one of the most important predictors of overall survival and six-month progression free survival. Unfortunately, it is often difficult in surgery to distinguish between tumor and normal brain. Various technologies have been developed to help the surgeon more readily safely increase extent of resection in order to achieve an improved survival after glioblastoma resection. Fluorescein has been used at some institutions for a number of years to improve visualization of high-grade gliomas enabling their better resection. Intraoperative MRI has also been developed with similar intent, allowing the patient to be imaged intraoperatively to determine extent of resection and any need for further resection prior to leaving the operating room. While there is some evidence these technologies improve extent of resection in comparison to historical controls, they have never been tested against each other in any prospective fashion.

Intraoperative MRI has significant cost and significantly increases operative time. Fluorescein is a very inexpensive injectable agent and, if as good at achieving gross total resection as intraoperative MRI, would offer patients similar surgical outcomes with less anesthetic time and cost than intraoperative MRI. This study aims to investigate the value of fluorescein or intraoperative MRI in malignant glioma patients' extent of tumor resection in a prospectively randomized manner.

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

    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Anschutz Medical Campus

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:

  • Presents with presumed or pathologically proven enhancing primary or secondary high grade glioma for surgical resection
  • Eligible for gross total resection of enhancing component of tumor
  • Karnofsy performance status >/= 70%

Exclusion Criteria:

  • Presence of multi-focal disease
  • Disease that crosses the mid-line
  • History of adverse reaction to flourescein
  • Known ongoing pregnancy
  • Inability to grant consent
  • Contraindication to perform iMRI
  • Contraindication to flourescein

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:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Arm A
Flourescein plus intraoperative MRI
fluorescein and conventional neuro-navigation
conventional neuro-navigation and iMRI
其他名称:
  • 磁共振成像
有源比较器:Arm B
intraoperative MRI alone
conventional neuro-navigation and iMRI
其他名称:
  • 磁共振成像

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
Extent of resection
大体时间:36 hours
This outcome will utilize tumor volumetry of residual enhancing tumor after resection.
36 hours

次要结果测量

结果测量
措施说明
大体时间
Surgical time difference
大体时间:36 hours
This outcome will evaluate the difference in length of surgery time between each arm.
36 hours

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:David R Ormond, MD、University of Colorado, Denver

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 (预期的)

2015年3月1日

初级完成 (实际的)

2018年7月18日

研究完成 (实际的)

2018年7月18日

研究注册日期

首次提交

2015年9月1日

首先提交符合 QC 标准的

2015年9月1日

首次发布 (估计)

2015年9月3日

研究记录更新

最后更新发布 (实际的)

2018年7月20日

上次提交的符合 QC 标准的更新

2018年7月18日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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