Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
|Squamous Cell Carcinoma of the Head and Neck||Drug: 18F-EF5 Procedure: Pretreatment PET/CT-scan (performed two times)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer|
- 18F-EF5 standardized uptake values (SUV) [ Time Frame: 2-3 years ]Volume of interests (VOIs) are determined in the acquisition images of the [18F]EF5 studies. The spatial overlap of the VOIs of the two [18F]EF5 studies will be evaluated.
- Event-free and overall survival [ Time Frame: 2-3 years ]
- Association of uptake of [18F]EF5 with molecular markers known to be associated in hypoxia and malignant progression [ Time Frame: 2-3 years ]
|Study Start Date:||March 2013|
|Study Completion Date:||September 2016|
|Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
|Experimental: 18F-EF5 PET/CT scan||Drug: 18F-EF5 Procedure: Pretreatment PET/CT-scan (performed two times)|
All patients will undergo normal diagnostic and staging procedures, including a conventional 18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an 18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous injection of 250-350 MBq of [18F]EF5. After that, a venous blood sample will be obtained for measurement of plasma radioactivity. A low-dose CT (helical) will be performed for attenuation correction and anatomical reference. After that, a PET scan will be performed (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way 4-7 days after the first scan. A representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis.
Patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. Follow-up information (event-free survival and overall survival) will be gathered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774760
|Turku University Hospital|
|Turku, Finland, FI-20521|
|Principal Investigator:||Heikki Minn, Professor||Turku University Hospital|