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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Hypoxia Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

London Health Science Center

London, Ontario, N6A 5W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET/CT

Device

All study participates will be scanned with PET/CT scan before surgery.

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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Nov 2, 2006
Registry last updated: Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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