PET/CT to Image Hypoxia in Head and Neck Tumours

Head and Neck Cancer Clinical Trial

Official title:

PET/CT to Image Hypoxia in Head and Neck Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395109
• Other study ID #: R-06-370
• Secondary ID: 12660
• Status: Completed
• Phase: Early Phase 1
• First received: November 1, 2006
• Last updated: August 25, 2017
• Start date: November 8, 2006
• Est. completion date: December 31, 2009

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 31, 2009
• Est. primary completion date: November 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anoxia
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	London Health Science Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions;		2 years
Primary	Measurement of mRNAs levels encoding hypoxia response genes in tumor samples.		2 years