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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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.
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.
Phase I: 2 years, Phase II: 5 years
Alexander J.B. McEwan, MB, MSc, BS
Cross Cancer Institute
Canada: Health Canada