Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer (FAITH)
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|ClinicalTrials.gov Identifier: NCT03181035|
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : October 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tongue Cancer||Radiation: (18)F-Fluoroazomycin arabinoside Drug: Pimonidazole||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Defining a Personalized Hypoxic Radiation Target Through Correlation of Functional F18-FAZA PET Imaging to Pimonidazole-stained 3D Whole-mounted Histological Specimen|
|Actual Study Start Date :||January 25, 2018|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||June 30, 2024|
Experimental: FAZA and pimonidazole
(18)F-Fluoroazomycin arabinoside (FAZA) will be administered via intravenous injection at a dose of 5.2 MBq/kg with a minimum dose of 200 Megabecquerel (MBq) (5.4 Millicurie (mCi)) and a maximum dose of 600 MBq (16.2 mCi) prior to positron emission tomography (PET) imaging. A single dose of oral pimonidazole capsules at a dose of 0.5 g/m2, will be taken by participants 16-20 hours prior to tumor resection surgery.
Radiation: (18)F-Fluoroazomycin arabinoside
FAZA PET diagnostic testing
Other Name: FAZA
oral pimonidazole hypoxia labeling
- Cellular hypoxia correlation [ Time Frame: 1 year ]The degree to which hypoxic signal measured by FAZA-PET imaging is correlated with true cellular hypoxia confirmed by immunohistochemical staining of pimonidazole using a 3D whole-mount approach
- Hypoxic reference standard [ Time Frame: 1 year ]A reference standard hypoxic radiation target will be defined through the correlation of functional F18-FAZA PET imaging to a pimonidazole-stained 3D whole mounted histological specimen.
- Registration quality [ Time Frame: 1 year ]The quality of registration will be assessed through measuring registration error of various automatic and semi-automatic co-registration techniques
- Textural feature comparison [ Time Frame: 1 year ]Potential relationships between textural features of MRI, PET-CT, and immunohistochemistry will be evaluated.
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): NCT03181035
|Contact: Ian Poon, MD, FRCPC||416-480-6100 ext firstname.lastname@example.org|
|Odette Cancer Centre, Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Ian Poon, MD, FRCPC 416-480-6100 ext 4951 email@example.com|
|Principal Investigator:||Ian Poon, MD, FRCPC||Sunnybrook Health Sciences Centre|