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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: fludeoxyglucose F 18; Radiation: Fluorine F 18 EF5; Procedure: Positron emission tomography

• Registration Number: NCT01017133
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	Fluorine F 18 EF5	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.
Arm I	Positron emission tomography	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.
Arm I	fludeoxyglucose F 18	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States