A Phase 1 interventional study of fludeoxyglucose F 18 and Fluorine F 18 EF5 in Non-small Cell Lung Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-26.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 1, Interventional, and Diagnostic
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.
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 56 is close to the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
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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 · Radiation: Fluorine F 18 EF5 · Procedure: Positron emission tomography
Given IV
Also known as: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F18
Given IV
Also known as: 18F-EF5
Undergo scan
Also known as: 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
The record gives a start of May 2009, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Abramson Cancer Center at Penn Medicine →