NCT00690053已完成1 期
Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study
Maastricht Radiation Oncology2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Toxicity (CTCAE 3.0)
研究概览
简要总结
Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia.
详细描述
To determine the toxicity of the hypoxia PET-tracer [18F]-HX4 in cancer patients in two dose-steps:
- Step 1 (3-6 patients): a single dose of maximum 6 mCi (222 MBq) dose of [18F]HX4 (which contains a maximum of 15 μg HX-4) via a bolus IV injection.
- Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of [18F]HX4 (which contains a maximum of 27 μg HX-4) 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
- Single (Participant)
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.
- •Normal white blood cell count and neutrophils
- •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
- •Capable of complying with study procedures
排除标准
- 未提供
结局指标
主要结局
Toxicity (CTCAE 3.0)
时间窗: 9 months
次要结局
- Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan)(9 months)
研究者
研究点 (2)
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