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

Not Applicable

Completed

Interventions: Drug: fluorine F18 EF5
Procedure: immunohistochemistry staining method
Procedure: biopsy
Procedure: Positron Emission tomography

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Patients must have a histologically confirmed and/or clinical and imaging evidence of a Stage 1-4 de novo mass in the larynx, pharynx or oral cavity
Treatment plan should include Surgery (Biopsy or Excision) and may be followed by radiation and/ or concurrent chemotherapy
Patients' disease must not require emergency surgical attention
The need for tracheotomy and/or feeding tube placement preceding definitive surgery is not a contradiction for participation
Patients must have a Karnofsky performance status >= 70
Patients must have a clinical condition and physiologic status for which the standard initial therapy is surgical biopsy or resection
Patients must have normal organ and marrow function as defined below:
WBC > 2,000/mm^3
Platelets > 100,000/mm^3
Total bilirubin
Creatinine
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month)
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Serum pregnancy testing will be required for women of childbearing age
Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5
Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women and women who are breastfeeding
Patients whose clinical status requires that surgery for their HNSCC be performed emergently or in a time course that does not allow scheduling of an 18F-EF5 PET scan preceding surgery and chemoradiation

Arm && Interventions

Group	Intervention	Description
Arm I	fluorine F18 EF5	Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
Arm I	biopsy	Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
Arm I	immunohistochemistry staining method	Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.
Arm I	Positron Emission tomography	Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection.

Primary Outcome Measures

Name	Time	Method
Tumor to normal tissue (T:N) ratios	Study completion	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.
18F-EF5 standardized uptake values (SUV)	Study completion	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.

Secondary Outcome Measures