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
|ClinicalTrials.gov Identifier: NCT01017133|
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : September 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Radiation: fludeoxyglucose F 18 Radiation: Fluorine F 18 EF5 Procedure: Positron emission tomography||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects With Non-Small Cell Lung Cancer|
|Study Start Date :||May 2009|
|Primary Completion Date :||September 2012|
|Study Completion Date :||September 2012|
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
Other Name: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F18Radiation: Fluorine F 18 EF5
Other Name: 18F-EF5Procedure: Positron emission tomography
Other Name: FDG-PET, PET, PET scan, tomography, emission computed
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017133
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|