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

November 1, 2006
February 10, 2009
January 2007
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • FDG/PET visualization of glycolysis in tumors and intra-tumor regions;
  • Measurement of mRNAs levels encoding hypoxia response genes in tumor samples.
  • CT visualization of blood flow in tumors and intra-tumor regions;
Complete list of historical versions of study NCT00395109 on ClinicalTrials.gov Archive Site
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PET/CT to Image Hypoxia in Head and Neck Tumours
PET/CT to Image Hypoxia in Head and Neck Tumours

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.

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.

Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Head and Neck Cancer.
Device: PET/CT
All study participates will be scanned with PET/CT scan before surgery.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
17
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: John Yoo, MD 519-6858457 john.yoo@lhsc.on.ca
Canada
 
NCT00395109
R-06-370, 12660
No
Dr. John Yoo, London Health Science Center
Lawson Health Research Institute
Not Provided
Principal Investigator: John Yoo, MD Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada
Lawson Health Research Institute
February 2009

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