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Clinical Trials/NCT00395109
NCT00395109
Completed
Early Phase 1

PET/CT to Image Hypoxia in Head and Neck Tumours

Lawson Health Research Institute1 site in 1 country17 target enrollmentNovember 8, 2006

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Lawson Health Research Institute
Enrollment
17
Locations
1
Primary Endpoint
FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions;
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2006
End Date
December 31, 2009
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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