NCT02389530已完成不适用
Use of Fluorescein Dye for the Removal of Brain Tumors
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
- 否
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
研究点 (1)
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