A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- More complete resection of malignant brain tumors
研究概览
简要总结
A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.
详细描述
Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial. Each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected primary brain tumor
- •18 years of age or more
- •Normal marrow and organ function
- •Eastern Cooperative Group performance status ≤ 2
- •Women of childbearing potential must use adequate birth control
- •Ability to understand and willingness to sign a written informed consent form
- •Life expectancy not a consideration
排除标准
- •Receiving any other investigational agents
- •History of allergic reactions to ALA
- •Personal or family history of porphyrias
- •Liver disease in the past year
- •Uncontrolled intercurrent illness
- •Pregnant or lactating women
- •Inability to undergo MRI with contrast
研究组 & 干预措施
Single-Arm
Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.
干预措施: Aminolevulinic Acid (Drug)
结局指标
主要结局
More complete resection of malignant brain tumors
时间窗: 3-7 days
次要结局
- Safety of drug(1 month)
研究者
Matthew R Quigley
administrator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)