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PET/CT to Image Hypoxia in Head and Neck Tumours

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
PET/CT
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring cancer, hypoxia, PET scan, CT scan

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Science Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 2006
Last Updated
August 25, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00395109
Brief Title
PET/CT to Image Hypoxia in Head and Neck Tumours
Official Title
PET/CT to Image Hypoxia in Head and Neck Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 8, 2006 (Actual)
Primary Completion Date
November 30, 2009 (Actual)
Study Completion Date
December 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
cancer, hypoxia, PET scan, CT scan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PET/CT
Intervention Description
All study participates will be scanned with PET/CT scan before surgery.
Primary Outcome Measure Information:
Title
FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions;
Time Frame
2 years
Title
Measurement of mRNAs levels encoding hypoxia response genes in tumor samples.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Yoo, MD
Organizational Affiliation
Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Science Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

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PET/CT to Image Hypoxia in Head and Neck Tumours

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