Clinical trial NCT00395109: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Head and Neck Cancer
Keywords: cancer
hypoxia
PET scan
CT scan
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2006-11-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions;
timeFrame: 2 years
measure: Measurement of mRNAs levels encoding hypoxia response genes in tumor samples.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Center
state: Ontario
Study officials:
affiliation: Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada
name: John Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References: