Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours

Titre officiel

A Phase I/II Imaging Study of 1-a-D-(5-deoxy-5-[18]F-fluoroarabinofuranosyl)-2-nitroimidazole ([18]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

Sommaire:

Cette étude a pour but de déterminer l’innocuité du 1-α-D-(5-désoxy-5-[18F]fluoroarabino-furanosyl)‑2-nitroimidazole (18F-FAZA) mis au point par le centre de tomographie par émission de positons établi à Edmonton, et de vérifier si le 18F-FAZA révélera les tumeurs hypoxiques dans le cas du cancer de la tête et du cou, du cancer du cerveau, du cancer du poumon ou d’un lymphome.

Description de l'essai

Primary Outcome:

• 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.

Secondary Outcome:

• Determine the relative tumour uptake of 18F-FAZA
• Confirm the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre

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.

Voir cet essai sur ClinicalTrials.gov