PET/CT to Image Hypoxia in Head and Neck Tumours

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00395109
Collaborator
(none)
17
1
37.7
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PET/CT
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
PET/CT to Image Hypoxia in Head and Neck Tumours
Actual Study Start Date :
Nov 8, 2006
Actual Primary Completion Date :
Nov 30, 2009
Actual Study Completion Date :
Dec 31, 2009

Outcome Measures

Primary Outcome Measures

  1. FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions; [2 years]

  2. Measurement of mRNAs levels encoding hypoxia response genes in tumor samples. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 London Health Science Center London Ontario Canada N6A 5W9

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

  • Principal Investigator: John Yoo, MD, Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00395109
Other Study ID Numbers:
  • R-06-370
  • 12660
First Posted:
Nov 2, 2006
Last Update Posted:
Aug 28, 2017
Last Verified:
Aug 1, 2017
Keywords provided by Lawson Health Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2017