A Phase I/II, Open Label, Nonrandomized, Multi-Center Study of [F-18]HX4 Positron Emission Tomography (PET) in Head and Neck Cancer Patients
Each consented patient will have a single administration of [F-18]HX4 and will immediately
undergo one list mode PET/CT imaging session lasting 60 minutes followed by three additional
list mode PET/CT acquisitions from 90 to 110 minutes, 150 to 170 minutes and 220 to 250
minutes after administration. The start times of the last three image acquisitions are
permitted to be within ± 5 minutes. Venous blood samples will be collected throughout the
initial scan sequence and at the time of each subsequent acquisition for calibration and
metabolite-correction of the image-derived input function. On the day of administration
(Visit 2) blood for clinical safety evaluations will be drawn pre- and post-dosing after all
imaging is complete.
The pre-surgery [F-18]FDG PET/CT clinical scan performed prior to the [F-18]HX4 procedure,
and the surgery at Visit 3 are standard of care for the consented patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Serial measures of T/B Ratios and other imaging parameters
Serial measures of T/B ratios and other imaging parameters derived from the course imaging data of head and neck cancer pateitns in order to determine time of optimal imaging.
Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out
John Buatti, MD
University of Iowa Medical Center
United States: Food and Drug Administration
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