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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoxic Tumours

Intervention / Treatment
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* Other: 18F-FAZA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>First 5 consecutive 18F-FAZA avid subjects that undergo up to 5 PET scans, 13 blood and 2 urine samples over 4.5 hours | Other: 18F-FAZA<br>* Radioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient<br>|
| 2<br>Next 5 consecutive 18F-FAZA avid subjects that undergo up to 4 PET scans, 8 blood and 2 urine samples over 5.5 hours | Other: 18F-FAZA<br>* Radioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine radiation dosimetry and optimal imaging times |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-FAZA, Positron Emission Tomography, Radiation dosimetry, Pharmacokinetics