Squamous Cell Carcinoma Clinical Trial
Official title:
Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?
Rationale: Diagnostic procedures, such as positron emission tomography, using the drug
fluorine F 18-EF5 to find oxygen in tumor cells may help in planning cancer treatment.
Purpose: This clinical trial studies fluorine F 18-EF5 positron emission tomography in
assessing hypoxia in patients with newly diagnosed stage I, stage II, stage III, or stage IV
squamous cell cancer of the oral cavity, oropharynx, and larynx.
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.
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