Working… Menu

PET/CT to Image Hypoxia in Head and Neck Tumours

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. Identifier: NCT00395109
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : August 28, 2017
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Head and Neck Cancer Device: PET/CT Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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
Actual Study Start Date : November 8, 2006
Actual Primary Completion Date : November 30, 2009
Actual Study Completion Date : December 31, 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: PET/CT
    All study participates will be scanned with PET/CT scan before surgery.

Primary Outcome Measures :
  1. FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions; [ Time Frame: 2 years ]
  2. Measurement of mRNAs levels encoding hypoxia response genes in tumor samples. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT00395109

Layout table for location information
Canada, Ontario
London Health Science Center
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Layout table for investigator information
Principal Investigator: John Yoo, MD Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada

Layout table for additonal information
Responsible Party: Lawson Health Research Institute Identifier: NCT00395109     History of Changes
Other Study ID Numbers: R-06-370
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Keywords provided by Lawson Health Research Institute:
PET scan
CT scan
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Signs and Symptoms, Respiratory
Signs and Symptoms