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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01017133

First received: November 18, 2009

Last updated: September 25, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 18, 2009
Last Updated Date	September 25, 2012
Start Date ^ICMJE	May 2009
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 19, 2009)	P-Akt in tumor cells as assessed by immunohistochemistry [ Designated as safety issue: No ] Tumor hypoxia as assessed by 18F-EF5 PET imaging [ Designated as safety issue: No ] Tumor Glycolysis as assessed by 18F-FDG PET imaging [ Designated as safety issue: No ] Progression-free survival [ Designated as safety issue: No ] Overall survival [ Designated as safety issue: No ] Toxicity assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01017133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects With Non-Small Cell Lung Cancer
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 Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Non-small Cell Lung Cancer
Intervention ^ICMJE	Radiation: fludeoxyglucose F 18 Given IV Other Name: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F18 Radiation: Fluorine F 18 EF5 Given IV Other Name: 18F-EF5 Procedure: Positron emission tomography Undergo scan Other Name: FDG-PET, PET, PET scan, tomography, emission computed
Study Arm (s)	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. Interventions: Radiation: fludeoxyglucose F 18 Radiation: Fluorine F 18 EF5 Procedure: Positron emission tomography
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	56
Completion Date	September 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01017133
Other Study ID Numbers ^ICMJE	UPCC 01509
Has Data Monitoring Committee	Yes
Responsible Party	Abramson Cancer Center of the University of Pennsylvania
Study Sponsor ^ICMJE	Abramson Cancer Center of the University of Pennsylvania
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abramson Cancer Center of the University of Pennsylvania
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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