Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours
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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 |
- 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.
- 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: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (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 |
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| Contact: Lai Schrader | 780-432-8464 | Lai.Schrader@albertahealthservices.ca |
| Contact: Margaret Landon | 780-432-8751 | Margaret.Landon@albertahealthservices.ca |
| Canada, Alberta | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Sub-Investigator: John Mercer, BSc, MSc, PhD | |
| Sub-Investigator: Emmanuel Hudson, BMedSc, MD | |
| Principal Investigator: | Alexander J.B. McEwan, MB, MSc, BS | Cross Cancer Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Alberta Health Services |
| 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: | March 15, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Lymphoma Neuroendocrine Tumors Head and Neck Neoplasms Glioblastoma 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 Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013