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
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|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|
|Actual Primary Completion Date :||September 2012|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|