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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00323076
• Other study ID #: DX-FAZ-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 12, 2006
• Est. completion date: February 4, 2019

Study information

• Verified date: February 2019
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Neuroendocrine Tumors
• Neuroendocrine Tumours
• Renal Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Postema EJ, McEwan AJ, Riauka TA, Kumar P, Richmond DA, Abrams DN, Wiebe LI. Initial results of hypoxia imaging using 1-alpha-D: -(5-deoxy-5-[18F]-fluoroarabinofuranosyl)-2-nitroimidazole ( 18F-FAZA). Eur J Nucl Med Mol Imaging. 2009 Oct;36(10):1565-73. doi: 10.1007/s00259-009-1154-5. Epub 2009 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Determine the relative tumour uptake of 18F-FAZA	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.	5 years
Secondary	Confirm the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre	Adverse event collection	5 years

External Links

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