Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours
Positron Emission Tomography (PET) is a Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to visualize biological activity. The presence of hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and treatment strategies targeting hypoxic cells have been developed. The PET tracer F-FAZA can identify hypoxic areas, and changes in uptake during treatment may predict tumour response.
Renal Cell Carcinoma
Drug: 18F-FAZA PET Imaging
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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|
- 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Adverse event collection
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
The proposed clinical trial will be a Phase I/II imaging, open label, single site study. In Phase I, one 18F-FAZA PET scan will be conducted in patients with known squamous cell carcinoma of the Head & Neck, SCLC, NSCLC, lymphoma, GGM, neuroendocrine tumours or renal cell carcinoma. In Phase II, three 18F-FAZA PET scans will be done on patients with the above tumours as follows: one pre-treatment, one mid course and one post-treatment.
Please refer to this study by its ClinicalTrials.gov identifier: 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|