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PET/CT to Image Hypoxia in Head and Neck Tumours

Phase 0
18 Years
80 Years
Open (Enrolling)
Head and Neck Cancer.

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Trial Information

PET/CT to Image Hypoxia in Head and Neck Tumours

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions;

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

John Yoo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada


Canada: Ethics Review Committee

Study ID:




Start Date:

January 2007

Completion Date:

December 2009

Related Keywords:

  • Head and Neck Cancer.
  • cancer
  • hypoxia
  • PET scan
  • CT scan
  • Head and Neck Neoplasms
  • Anoxia