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PET/CT to Image Hypoxia in Head and Neck Tumours

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00395109
First Posted: November 2, 2006
Last Update Posted: August 28, 2017
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.
Information provided by (Responsible Party):
Lawson Health Research Institute
  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 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 ]

Enrollment: 17
Actual Study Start Date: November 8, 2006
Study Completion Date: December 31, 2009
Primary Completion Date: November 30, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00395109


Locations
Canada, Ontario
London Health Science Center
London, Ontario, Canada, N6A 5W9
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

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00395109     History of Changes
Other Study ID Numbers: R-06-370
12660
First Submitted: November 1, 2006
First Posted: November 2, 2006
Last Update Posted: August 28, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Hypoxia
Neoplasms by Site
Neoplasms
Signs and Symptoms, Respiratory
Signs and Symptoms