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临床试验/NCT01767415
NCT01767415已完成1 期

Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Extent of Resection

研究概览

简要总结

The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.

详细描述

Low grade gliomas are brain tumors with usually poorly defined borders between tumor and normal brain. This characteristic of low grade gliomas makes the gross total resection of the tumor extremely difficult. Nevertheless, several studies have demonstrated that the risk of recurrence and progression into a more malignant tumor can be decreased with a more aggressive surgical resection. An aggressive attempt to achieve a gross total resection may result in the resection of normal brain and therefore neurological injury. For this reason, the more common error is to subtotally resect the tumor leaving significant volumes of tumor behind. Many techniques have been introduced to safely increase the extent of resection, since the extent of resection is associated with a higher survival rate. Each one of these techniques has several shortcomings. The current study will assess whether the intraoperative stereotactic injection of the indigo carmine at the tumor margins helps to safely increase of extent of tumor resection. In the first step of the study the safety and the correlation between resection of stained tissue/extend of tumor resection will be assessed. If the results are satisfactory, then the second step will ensue. In the second step we will assess the utility of indigo carmine as an additional adjunct to guide tumor resection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with gliomas or other tumors that may have ill defined margins during the operative resection.

排除标准

  • Subjects with a contraindication for brain MRI scan. Subjects who are pregnant, younger than 18 years old or have a contraindication for indigo carmine are excluded as well

研究组 & 干预措施

Indigo Carmine

Experimental

Intraoperative stereotactic injection of Indigo Carmine

干预措施: Indigo carmine (Drug)

结局指标

主要结局

Extent of Resection

时间窗: 48 hours

Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.

次要结局

  • Absence of Complications After Injection(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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