Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?
Detailed DescriptionPRIMARY OBJECTIVES:
I. Describe the patterns and levels of 18F-EF5 in Stage 1 - 4 de novo HNSCC of the oral
cavity, oropharynx and larynx.
II. Determine whether the 18F-EF5 PET images are predictive of patient outcome (event-free
survival; EFS and overall survival; OS).
III. Determine whether any statistically significant prognostic relationships found in the
corresponding grant are independent of nodal status.
SECONDARY OBJECTIVES:
I. Explore the relationship between 18F-EF5 signal and other measures of hypoxia (serum OPN;
HIF1alpha protein expression), proliferation (Ki67+ cells/high power field (HPF)), apoptosis
and radiation resistance (pAkt expression).
OUTLINE:
Patients undergo fluorine F 18-EF5 positron emission tomography imaging. Scans are performed
180 minutes following injection.
After completion of study, patients are followed at 2-4 weeks and 4-6 weeks.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
18F-EF5 standardized uptake values (SUV)
No
United States: Institutional Review Board
UPCC 17308
NCT01020097
March 2009
March 2014
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |