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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01020097|
Recruitment Status : Unknown
Verified December 2015 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was: Active, not recruiting
First Posted : November 24, 2009
Last Update Posted : December 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma||Drug: fluorine F18 EF5 Procedure: immunohistochemistry staining method Procedure: biopsy Procedure: Positron Emission tomography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2013|
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
- 18F-EF5 standardized uptake values (SUV)
- Tumor to normal tissue (T:N) ratios
- Event-free survival and overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020097
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|