Fluorine F18-EF5 and Fludeoxyglucose F18 Positron Emission Tomography in Assessing Hypoxia and Glycolysis in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F18-EF5 to find oxygen and fludeoxyglucose F18 to find sugar in tumor cells may help in planning treatment for patients with non-small cell lung cancer.

Detailed Description
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PURPOSE: This clinical trial is studying fluorine F18-EF5 and fludeoxyglucose F18 positron emission tomography in assessing hypoxia and glycolysis in patients with stage I, stage II, or stage III non-small cell lung cancer.Detailed DescriptionOBJECTIVES: I. To determine whether there is an association between Akt activation and hypoxia as determine by 18F-EF5 PET scanning in patients with NSCLC. II. To determine whether there is an association between Akt activation and increased glycolysis as determined by 18F-FDG PET imaging in patients with NSCLC. OUTLINE: Within 6 weeks prior to surgery, patients undergo fluorine F18 (18F)-EF5 PET at 10 minutes and 90 minutes after injection of 18F-EF5. Patients also undergo fludeoxyglucose F18 (18F-FDG) PET at 1 hour and 3 hours after injection of 18FFDG. After completion of study treatment, patients are followed periodically for 5 years.

Official Title
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Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects With Non-Small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: fludeoxyglucose F 18
* Radiation: Fluorine F 18 EF5
* Procedure: Positron emission tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have a histologically confirmed NSCLC or clinical and imaging evidence of a de novo mass that is likely to be a NSCLC, stage I, II, or IIIA, for which surgery would be indicated for routine medical indications ECOG performance status between 0 and 2 Subjects must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits WBC > 2,000/mm^3 Platelet count > 100,000/mm^3 Total bilirubin Serum AST and ALT Serum creatinine Negative serum pregnancy test if a female of childbearing age Exclusion Criteria: History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5 Uncontrolled intercurrent illness that would limit compliance with study requirements Pregnant women and women who are breastfeeding are excluded Subjects who have been treated with neoadjuvant radiation or chemotherapy prior to their biopsy or excision are excluded because the impact of these therapies upon the degree of hypoxia of the tumor is unknown

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm I<br>With 6 weeks prior to surgery, patients undergo fluorine F18 (18F)-EF5 PET at 10 minutes and 90 minutes after injection of 18F-EF5. Patients also undergo fludeoxyglucose F18 (18F-FDG) PET at 1 hour and 3 hours after injection of 18F-FDG. | Radiation: fludeoxyglucose F 18<br>* Given IV<br>* Other names: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F18;Radiation: Fluorine F 18 EF5<br>* Given IV<br>* Other names: 18F-EF5;Procedure: Positron emission tomography<br>* Undergo scan<br>* Other names: FDG-PET, PET, PET scan, tomography, emission computed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P-Akt in tumor cells as assessed by immunohistochemistry |  |  | 
| Tumor hypoxia as assessed by 18F-EF5 PET imaging |  |  | 
| Tumor Glycolysis as assessed by 18F-FDG PET imaging |  |  | 
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Toxicity assessed by CTCAE v3.0 |  |  |