NCT00935142撤回1 期
Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial
Maastricht Radiation Oncology0 个研究点开始时间: 2012年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Toxicity (CTCAE 3.0)
研究概览
简要总结
The purpose of this study is to determine the toxicity of the hypoxia PET-tracer [18F]-VM4-037 in cancer patients in two dose-steps:
- Step 1 (3-6 patients): a single dose of maximum 8 mCi (296 MBq) dose of [18F]VM4-037 via a bolus IV injection.
- Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of [18F]VM4-037 via a bolus IV injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options
- •WHO performance status 0 to 1
- •Normal white blood cell count and formula
- •Normal platelet count
- •No anaemia requiring blood transfusion or erythropoietin
- •Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution)
- •Calculated Creatinin clearance at least 60 ml/min
- •No administration of Fluor-18 in the previous 24 hours
- •The patient is capable of complying with study procedures
- •18 years or older
排除标准
- •Only visible tumor sites in the upper abdomen (because the uptake of VM4-037 in the liver, stomach and the kidneys would interfere with image quality of the tumor)
- •Known hypersensitivity for sulfonamides
- •Recent (< 3 months) myocardial infarction
- •Uncontrolled infectious disease
- •Less than 18 years old
- •Pregnancy
- •No concurrent anti-cancer agents or radiotherapy allowed
结局指标
主要结局
Toxicity (CTCAE 3.0)
时间窗: 1 week
次要结局
- Image Quality(1 week)
- Correlation with circulating biomarkers of hypoxia(1 week)
- Correlation with [18F]-FDG on PET scans(1 week)
研究者
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