Imaging and Biomarkers of Hypoxia in Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.
研究概览
简要总结
Hypoxia, meaning a lack of oxygen, has been associated strongly with a wide range of human cancers. Hypoxia occurs when tumor growth exceeds the ability of blood vessels to supply the tumor with oxygenated blood. It is currently understood that hypoxic tumors are more aggressive. Current methods for measuring hypoxia include invasive procedures such as tissue biopsy, or insertion of an electrode into the tumor. EF5-PET may be a non-invasive way to measure tumor hypoxia.
详细描述
To establish PET imaging with the tracer EF5 as an accurate and reliable method for measuring the oxygen content of a tumor and to establish the measurement of secreted markers in blood as an accurate and reliable method for measuring the oxygen content of a tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Carbogen arm
干预措施: PET Scan (Procedure)
Carbogen arm
干预措施: EF5 (Drug)
Carbogen arm
干预措施: Carbogen (Drug)
DCA arm
干预措施: PET Scan (Procedure)
DCA arm
干预措施: EF5 (Drug)
DCA arm
干预措施: Dichloroacetate (Drug)
结局指标
主要结局
18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.
时间窗: 1-5 days
18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects.
时间窗: 1-5 days
次要结局
- Levels of secreted hypoxia markers in plasma.(1-5 days)
- Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection.(1-5 days)
研究者
Billy W. Loo Jr.
Associate Professor of Radiation Oncology
Stanford University