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
NCT ID: NCT01017133
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2009-05-31
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
fludeoxyglucose F 18
Given IV
Fluorine F 18 EF5
Given IV
Positron emission tomography
Undergo scan
Interventions
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fludeoxyglucose F 18
Given IV
Fluorine F 18 EF5
Given IV
Positron emission tomography
Undergo scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC 01509
Identifier Type: -
Identifier Source: org_study_id
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