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PET/CT to Image Hypoxia in Head and Neck Tumours

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Lawson Health Research Institute.
Recruitment status was:  Recruiting
Information provided by:
Lawson Health Research Institute Identifier:
First received: November 1, 2006
Last updated: February 10, 2009
Last verified: February 2009

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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Measurement of mRNAs levels encoding hypoxia response genes in tumor samples. [ Time Frame: 2 years ]

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00395109

Contact: John Yoo, MD 519-6858457

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

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

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Signs and Symptoms, Respiratory
Signs and Symptoms processed this record on August 18, 2017