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PET/CT to Image Hypoxia in Head and Neck Tumours

L

Lawson Health Research Institute

Status and phase

Completed
Early Phase 1

Conditions

Head and Neck Cancer

Treatments

Device: PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT00395109
R-06-370
12660

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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