PET/CT to Image Hypoxia in Head and Neck Tumours

Early Phase 1

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00395109
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study First Submitted: 2006-11-01
• Study First Submitted QC: 2006-11-01
• Study First Posted: 2006-11-02
• Study Start: 2006-11-08
• Primary Completion: 2009-11-30
• Study Completion: 2009-12-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• All patients with head and neck tumours (>3cm diameter) without bone involvement.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions;	2 years
Measurement of mRNAs levels encoding hypoxia response genes in tumor samples.	2 years

Trial Locations

Locations (1)

London Health Science Center; 🇨🇦 London, Ontario, Canada