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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
5
Given IV
Correlative study
Correlative study
Undergo scan
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
18F-EF5 standardized uptake values (SUV)
Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.
Time frame: Study completion
Tumor to normal tissue (T:N) ratios
Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.
Time frame: Study completion
Event-free survival and overall survival
Length of time from end of treatment to recurrence or death
Time frame: 5 years
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