Spots Global Cancer Trial Database for A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA

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Trial Identification

Brief Title: A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA

Official Title: A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA

Study ID: NCT00756691

Conditions

Hypoxic Tumours

Interventions

18F-FAZA

Study Description

Brief Summary: 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.

Detailed Description: 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.