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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT01020097
Study type Interventional
Source Abramson Cancer Center of the University of Pennsylvania
Contact
Status Completed
Phase N/A
Start date March 2009
Completion date December 2013

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