PET/CT to Image Hypoxia in Head and Neck Tumours
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|ClinicalTrials.gov Identifier: NCT00395109|
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : August 28, 2017
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|
|Head and Neck Cancer||Device: PET/CT||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET/CT to Image Hypoxia in Head and Neck Tumours|
|Actual Study Start Date :||November 8, 2006|
|Actual Primary Completion Date :||November 30, 2009|
|Actual Study Completion Date :||December 31, 2009|
- Device: PET/CT
All study participates will be scanned with PET/CT scan before surgery.
- FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions; [ Time Frame: 2 years ]
- Measurement of mRNAs levels encoding hypoxia response genes in tumor samples. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|