PET/CT to Image Hypoxia in Head and Neck Tumours

NCT ID: NCT00395109

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-08
• Study Completion Date: 2009-12-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

PET/CT

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

London Health Science Center

London, Ontario, Canada

Countries

Canada

Other Identifiers

12660

Identifier Type: -

Identifier Source: secondary_id

R-06-370

Identifier Type: -

Identifier Source: org_study_id