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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00323076
Recruitment Status : Unknown
Verified January 2014 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
First Posted : May 9, 2006
Last Update Posted : October 2, 2014
Information provided by (Responsible Party):
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2004
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

    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 :
  1. Determine the relative tumour uptake of 18F-FAZA [ Time Frame: 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.

  2. Confirm the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre [ Time Frame: 5 years ]
    Adverse event collection

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00323076

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Contact: Lai Schrader 780-432-8464
Contact: Margaret Landon 780-432-8751

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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
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Principal Investigator: Alexander J.B. McEwan, MB, MSc, BS Cross Cancer Institute

Additional Information:
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Responsible Party: AHS Cancer Control Alberta Identifier: NCT00323076     History of Changes
Other Study ID Numbers: SP-14-0050/DX-FAZ-001/22390
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neuroendocrine Tumors
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Fluoroazomycin arabinoside
Molecular Mechanisms of Pharmacological Action