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

Withdrawn

• Conditions: Hypoxic Tumours
• Interventions: Other: 18F-FAZA

• Registration Number: NCT00756691
• Lead Sponsor: AHS Cancer Control Alberta

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.

Study Timeline

• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	18F-FAZA	Next 5 consecutive 18F-FAZA avid subjects that undergo up to 4 PET scans, 8 blood and 2 urine samples over 5.5 hours
1	18F-FAZA	First 5 consecutive 18F-FAZA avid subjects that undergo up to 5 PET scans, 13 blood and 2 urine samples over 4.5 hours

Primary Outcome Measures

Name	Time	Method
To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.	2 years

Secondary Outcome Measures

Name	Time	Method
To determine radiation dosimetry and optimal imaging times	2 years