PET/CT to Image Hypoxia in Head and Neck Tumours

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00395109
First received: November 1, 2006
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

Patients with head and neck cancer will be imaged with PET scan and CT scan in order to determine areas of the tumour that are hypoxic.

It is hypothesized that PET /CT will provide information on hypoxia of the tumors and tumor regions in head and neck cancer patients.


Condition Intervention Phase
Head and Neck Cancer.
Device: PET/CT
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET/CT to Image Hypoxia in Head and Neck Tumours

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions; [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Measurement of mRNAs levels encoding hypoxia response genes in tumor samples. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 17
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PET/CT
    All study participates will be scanned with PET/CT scan before surgery.
Detailed Description:

Patients with head and neck cancer greater than 3 cm will imaged with PET scan and CT scan in order to determine areas of the tumour that are hypoxic. Following surgical removal, samples of the tumour will be evaluated for the expression of hypoxia genes. The preoperative imaging will be compared to the "gold standard" measures of hypoxic response at the level of gene transcription and a new hypoxia marker with the hypoxyprobe detection system (pimonidazole).

Hypothesis: FDG/PET visualization of glycolysis combined with CT visualization of blood flow will correlate with cellular response to hypoxic stress in head and neck tumors and intra-tumor regions. Measurement of relative levels of mRNAs encoding hypoxia response genes will be performed in cells microdissected from the surgical samples. Good correlation between imaging signals and direct molecular measures of hypoxic response in primary human tumors will provide information necessary to develop treatment strategies that employ targeted, increased radiation to hypoxic tumors.

Pimonidazole is an exogenous nitro-imidazole marker, which can be detected through immunohistochemical analysis of frozen sections. It detects cellular hypoxia upon becoming reduced in cells with low oxygen tension, a property that can be detected through antibody mediated detection of the reduced form. It has also shown to reliably and specifically stain hypoxic regions within the tumor, and to correlate well with patient prognosis and treatment outcome.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with head and neck tumours (>3cm diameter) without bone involvement.

Exclusion Criteria:

  • Known allergy to contrast agents
  • Poor kidney function (serum creatinine level > 2.0 mg/dL or 177 mmol/L)
  • Pregnancy
  • Breast-feeding
  • Unable to lie supine
  • Patient who were biopsied or operated upon within the past month.
  • Patient who were treated with chemotherapy or radiation within the past month.
  • Tumors that were obscured by artifacts (e.g. tooth fillings) in CT scans.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395109

Contacts
Contact: John Yoo, MD 519-6858457 john.yoo@lhsc.on.ca

Locations
Canada, Ontario
London Health Science Center Recruiting
London, Ontario, Canada, N6A 5W9
Contact: John Yoo, MD    519-6858457    john.yoo@lhsc.on.ca   
Principal Investigator: John Yoo, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: John Yoo, MD Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada
  More Information

No publications provided

Responsible Party: Dr. John Yoo, London Health Science Center
ClinicalTrials.gov Identifier: NCT00395109     History of Changes
Other Study ID Numbers: R-06-370, 12660
Study First Received: November 1, 2006
Last Updated: February 10, 2009
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
cancer
hypoxia
PET scan
CT scan

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014