A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients
The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for future studies involving [F-18]HX4 in cancer patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase I/II, Open Label, Nonrandomized, Multi-Center Study of [F-18]HX4 Positron Emission Tomography (PET) in Head and Neck Cancer Patients|
- Serial measures of T/B Ratios and other imaging parameters [ Time Frame: Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out ] [ Designated as safety issue: No ]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.
- Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements [ Time Frame: Estimated analysis to occur 1 month after patient surgery ] [ Designated as safety issue: No ]Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements obtained from surgical tumor samples
- Kinetic Modeling Analysis [ Time Frame: Estimated to be 2 weeks after the Imaging Date (Visit 2) ] [ Designated as safety issue: No ]Kinetic parameters obtained from modeling time course of PET imaging data following [F-18]HX4 administration
- Safety Assessments [ Time Frame: On average of 3 weeks (from Time of Signing Consent to 24 hours after the Imaging Date) ] [ Designated as safety issue: Yes ]Safety measurements including incidence of adverse events, and pre- and post-drug clinical laboratory measurements, vital signs and electrocardiograms
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Experimental: [F-18] HX4||
Radiation: [F-18] HX4
A single dose of 10 mCi, injected intravenously.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506427
|United States, Iowa|
|University of Iowa Medical Center|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||John Buatti, MD||University of Iowa Medical Center|
|Study Director:||Edward Aten, MD||President, Certus International|