NCT00323076

[18]F-FAZA PET Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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 \[18\]F-FAZA can identify hypoxic areas, and changes in uptake during treatment may predict tumour response.

Detailed description

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.

Conditions

• Renal Cell Carcinoma
• Neuroendocrine Tumours

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-09-12
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2006-05-09
• Last updated: 2019-08-26

Locations

1 site across 1 country: Canada