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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: fludeoxyglucose F 18; Radiation: Fluorine F 18 EF5; Procedure: Positron emission tomography

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm I; 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; Given IV; Other Names: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F18; Radiation: Fluorine F 18 EF5; Given IV; Other Names: 18F-EF5; Procedure: Positron emission tomography; Undergo scan; Other Names: FDG-PET, PET, PET scan, tomography, emission computed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
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
Toxicity assessed by CTCAE v3.0

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 19, 2009
• First Posted (Estimate): November 20, 2009

Study Record Updates

• Last Update Posted (Estimate): September 26, 2012
• Last Update Submitted That Met QC Criteria: September 25, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Signs and Symptoms, Respiratory; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Hypoxia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Protective Agents; Radiopharmaceuticals; Cariostatic Agents; Fluorodeoxyglucose F18; Fluorides; Deoxyglucose
• Other Study ID Numbers: UPCC 01509