Status:
WITHDRAWN
A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Hypoxic Tumours
Eligibility:
All Genders
18+ years
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 Pos...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00756691
Last Update
November 14 2017
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