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

Phase 1

Terminated

• Conditions: Neuroendocrine Tumours; Renal Cell Carcinoma
• Interventions: Drug: 18F-FAZA PET Imaging

• Registration Number: NCT00323076
• Lead Sponsor: AHS Cancer Control Alberta

Brief 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.

Study Timeline

• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-09
• Study Start: 2006-09-12
• Status Verified: 2019-02
• Primary Completion: 2019-02-04
• Study Completion: 2019-02-04
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Male or female greater than or equal to 16 years of age.
• If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
• Patients with known primary or suspected metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, GBM (greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma with at least one lesion >1 cm in diameter.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	18F-FAZA PET Imaging	18F-FAZA PET Imaging

Primary Outcome Measures

Name	Time	Method
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: 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.

Secondary Outcome Measures

Name	Time	Method
Determine the relative tumour uptake of 18F-FAZA	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	5 years	Adverse event collection

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada