Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours
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|ClinicalTrials.gov Identifier: NCT00323076|
Recruitment Status : Unknown
Verified January 2014 by AHS Cancer Control Alberta.
Recruitment status was: Recruiting
First Posted : May 9, 2006
Last Update Posted : October 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Neuroendocrine Tumours||Drug: 18F-FAZA PET Imaging||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Imaging Study of 1-a-D-(5-deoxy-5-F-fluoroarabinofuranosyl)-2-nitroimidazole (F-FAZA) in Patients With Known Squamous Cell Carcinoma of the Head & Neck, Small Cell and Non-Small Cell Carcinoma of the Lung, Lymphoma, Glioblastoma Multiforme, Neuroendocrine Tumours or Renal Cell Carcinoma|
|Study Start Date :||September 2004|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2015|
18F-FAZA PET Imaging
Drug: 18F-FAZA PET Imaging
Phase I: 110-600 MBq per injection. A single injection of 18F-FAZA and PET scan will be permitted per patient.
Phase II: 110-600 MBq per injection. Up to three separate injections of 18F-FAZA and PET scans will be permitted per patient.
- Phase I: demonstrate the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre. Phase II: determine the general biodistribution pattern of18F-FAZA. [ Time Frame: Phase I: 2 years, Phase II: 5 years ]
Phase I: Pre-injection and post-imaging vital signs, blood haematology and blood chemistry, adverse event collection.
Phase II: The location and relative uptake of normal and abnormal 18F-FAZA biodistribution patterns will be determined.
- Determine the relative tumour uptake of 18F-FAZA [ Time Frame: 5 years ]Measure relative uptake scores (RUS) and tumour to background ratios (T/B) and correlate this uptake to disease progression, disease-free survival, overall survival and response to treatment over 12 months of follow-up.
- Confirm the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre [ Time Frame: 5 years ]Adverse event collection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323076
|Contact: Lai Schrader||780-432-8464||Lai.Schrader@albertahealthservices.ca|
|Contact: Margaret Landon||780-432-8751||Margaret.Landon@albertahealthservices.ca|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Sub-Investigator: John Mercer, BSc, MSc, PhD|
|Sub-Investigator: Emmanuel Hudson, BMedSc, MD|
|Principal Investigator:||Alexander J.B. McEwan, MB, MSc, BS||Cross Cancer Institute|