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

This study is currently recruiting participants.
Verified January 2014 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00323076
First received: May 5, 2006
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
Neuroendocrine Tumours
Drug: 18F-FAZA PET Imaging
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • 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. [ Time Frame: Phase I: 2 years, Phase II: 5 years ] [ Designated as safety issue: Yes ]

    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:
  • Determine the relative tumour uptake of 18F-FAZA [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Adverse event collection


Estimated Enrollment: 160
Study Start Date: September 2004
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
18F-FAZA PET Imaging
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.


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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323076

Contacts
Contact: Lai Schrader 780-432-8464 Lai.Schrader@albertahealthservices.ca
Contact: Margaret Landon 780-432-8751 Margaret.Landon@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sub-Investigator: John Mercer, BSc, MSc, PhD         
Sub-Investigator: Emmanuel Hudson, BMedSc, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Alexander J.B. McEwan, MB, MSc, BS Cross Cancer Institute
  More Information

Additional Information:
Publications:
Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00323076     History of Changes
Other Study ID Numbers: SP-14-0050/DX-FAZ-001/22390
Study First Received: May 5, 2006
Last Updated: January 31, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Carcinoma, Squamous Cell
Glioblastoma
Lymphoma
Neuroendocrine Tumors
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Squamous Cell
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on April 16, 2014