A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
2016年3月15日 更新者：MultiCare Health System Research Institute
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor.
The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light.
During surgery an ultraviolet light in the microscope chain will be turned on.
The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue.
The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.
研究概览
详细说明
This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery.
Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor.
After surgery an MRI will be done to determine whether the tumor has been completely or partially resected.
All subjects will be followed for safety.
All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.
研究类型
介入性
注册 (实际的)
16
阶段
- 阶段2
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
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Washington
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Tacoma、Washington、美国、98405
- MultiCare Health System Research Institute
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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:
- Clinically documented primary brain tumor for which surgical resection is indicated.
- Age 18 years and older.
- ECOG Performance status less than or equal to 2.
- Laboratory values as follows:
Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.
-Ability to provide informed consent or consent from a Legally Authorized Representative.
Exclusion Criteria:
- Receipt of an investigational agent within 30 days.
- Allergy to ALA or similar compounds.
- Personal or family history of porphyria.
- Uncontrolled intercurrent illness.
- Inability to comply with the protocol.
- Pregnancy, breastfeeding.
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：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Aminolevulinic Acid (AL)
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Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
其他名称：
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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 |
|---|---|---|
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Time to disease progression after initial surgery.
大体时间：Up to 2 years
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Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
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Up to 2 years
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Complete Resection
大体时间：Day 2
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Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls
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Day 2
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Determine the number of subjects with adverse events due to ALA in this dosage and indication.
大体时间：Through 45 days
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Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur.
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Through 45 days
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Overall Survival
大体时间：Up to three years
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Determine the overall survival compared to historical controls.
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Up to three years
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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：William Morris, MD、MultiCare Health System
- 研究主任：Richard Shine, PharmD, BCPS、MultiCare Health System Research Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2011年5月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2011年5月7日
首先提交符合 QC 标准的
2011年5月9日
首次发布 (估计)
2011年5月11日
研究记录更新
最后更新发布 (估计)
2016年3月17日
上次提交的符合 QC 标准的更新
2016年3月15日
最后验证
2016年3月1日
更多信息
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.
Aminolevulinic Acid的临床试验
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University College, LondonImperial College London; Cancer Research UK; National Cancer Imaging Translational Accelerator招聘中
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University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)招聘中
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Gladwin, Mark, MDNational Heart, Lung, and Blood Institute (NHLBI); Complexa, Inc.终止
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Critical Outcome Technologies Inc.M.D. Anderson Cancer Center; Northwestern Memorial Hospital未知宫颈癌 | 头颈癌 | 大肠癌 | 胰腺癌 | 卵巢癌 | 输卵管癌 | 肺癌 | 子宫内膜癌 | 腹膜癌 | HNSCC美国