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Trial record 92 of 2759 for:    Neoplasms | Neuroendocrine Tumors

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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Tracking Information
First Submitted Date  ICMJE May 5, 2006
First Posted Date  ICMJE May 9, 2006
Last Update Posted Date October 2, 2014
Study Start Date  ICMJE September 2004
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
  • establish the safety of 18F-FAZA PET manufactured at the Edmonton PET Centre
  • determine the biodistribution pattern of 18F-FAZA
Change History Complete list of historical versions of study NCT00323076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • 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.
  • Confirm the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre [ Time Frame: 5 years ]
    Adverse event collection
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
determine the relative tumour uptake of 18F-FAZA by measuring relative uptake scores and tumour to background ratios
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Renal Cell Carcinoma
  • Neuroendocrine Tumours
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: 1
18F-FAZA PET Imaging
Intervention: Drug: 18F-FAZA PET Imaging
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 15, 2012)
160
Original Enrollment  ICMJE
 (submitted: May 5, 2006)
10
Estimated Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323076
Other Study ID Numbers  ICMJE SP-14-0050/DX-FAZ-001/22390
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AHS Cancer Control Alberta
Study Sponsor  ICMJE AHS Cancer Control Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander J.B. McEwan, MB, MSc, BS Cross Cancer Institute
PRS Account AHS Cancer Control Alberta
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP