Skip to content

PET/CT to Image Hypoxia in Head and Neck Tumours

PET/CT to Image Hypoxia in Head and Neck Tumours

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00395109
Enrollment
17
Registered
2006-11-02
Start date
2006-11-08
Completion date
2009-12-31
Last updated
2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

cancer, hypoxia, PET scan, CT scan

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.

Interventions

DEVICEPET/CT

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

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026