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临床试验/NCT02389530
NCT02389530已完成不适用

Use of Fluorescein Dye for the Removal of Brain Tumors

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Adverse event assessment

研究概览

简要总结

Fluorescein is a dye agent that can be injected through an intravenous line. It has been shown to help tell the difference between brain tumor tissue and normal brain tissue when it is used together with a specialized filter on a microscope in the operating room. The investigators plan to study the use of fluorescein in the removal of brain tumors at a low dose.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age of 18 or greater
  • Plan for elective removal of a brain tumor at UPMC Shadyside with either Dr. Engh or Dr. Amankulor.

排除标准

  • History of adverse reaction to fluorescein.
  • Emergent surgical procedure (consent not feasible).
  • Creatinine of > 2.0 (drug is excreted renally).
  • Known ongoing pregnancy.

研究组 & 干预措施

interventional group

All participants will receive the study intervention, intravenous administration of fluorescein dye prior to brain tumor removal.

干预措施: Fluorescein (Drug)

结局指标

主要结局

Adverse event assessment

时间窗: 3 years

Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis

次要结局

  • Degree of tumoral resection(3 years)
  • Clinical status after surgery(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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