Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.
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.
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