A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.
研究概览
简要总结
Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.
详细描述
A Phase I Radiopharmacokinetic and Radiodosimetric study of 18F-FAZA. Prior to treatment, subjects will receive a single injection of 18F-FAZA. Subjects will undergo a series of 5-5 PET scans, and will have 8-13 blood samples and 2 urine samples taken at specified time points over a 4.5-5.5 hour period. 18F-FAZA PET images will be reviewed to develop a dynamic uptake model, and blood and urine samples will be analyzed for unchanged 18F-FAZA and its metabolites.
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
- •Male of Female > or = to 18 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test required
- •Subjects with known primary or suspected metastatic SCC head and neck; NSCLC; SCLC; GBM; lymphoma, or NET with at least one lesion > 1 cm in diameter
- •Able and willing to follow instructions and comply with the protocol
- •Provide written informed consent prior to participation in the study
- •Karnofsky Performance Scale Score of 70-100
排除标准
- •Previous treatment for their primary or metastatic SCC head and neck, NSCLC, SCLC, GBM, Lymphoma, or NET
- •Bilirubin > or = to 200 umol/L
- •Creatinine > or - to 150 umol/L
- •AST or ALT > or = to 5 times the upper limits of normal
- •Serious medical conditions such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
- •Nursing or pregnant females
结局指标
主要结局
To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.
时间窗: 2 years
次要结局
- To determine radiation dosimetry and optimal imaging times(2 years)