PET/CT to Image Hypoxia in Head and Neck Tumours
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||PET/CT to Image Hypoxia in Head and Neck Tumours|
- FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions; [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Measurement of mRNAs levels encoding hypoxia response genes in tumor samples. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395109
|London Health Science Center|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator:||John Yoo, MD||Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada|