Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
18F-EF5 standardized uptake values (SUV)
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.
2-3 years
No
Heikki Minn, Professor
Principal Investigator
Turku University Hospital
Finland: Finnish Medicines Agency
T14/2013
NCT01774760
March 2013
January 2015
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