Fluorine F 18 EF5 Positron Emission Tomography in Assessing Hypoxia in Patients With Newly Diagnosed Stage I, Stage II, Stage III, or Stage IV Head or Neck Squamous Cell Cancer of the Oral Cavity, Oropharynx, and Larynx
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.
Squamous Cell Carcinoma
Drug: fluorine F18 EF5
Procedure: immunohistochemistry staining method
Procedure: Positron Emission tomography
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?|
- 18F-EF5 standardized uptake values (SUV) [ Designated as safety issue: No ]
- Tumor to normal tissue (T:N) ratios [ Designated as safety issue: No ]
- Event-free survival and overall survival [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
Drug: fluorine F18 EF5
Other Name: 18F-EF5Procedure: immunohistochemistry staining method
Other Name: immunohistochemistryProcedure: biopsy
Other Name: biopsiesProcedure: Positron Emission tomography
Other Name: FDG-PET, PET, PET scan, tomography, emission computed
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.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020097
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|