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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

November 18, 2009
September 25, 2012
May 2009
September 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01017133 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects With Non-Small Cell Lung Cancer

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Non-small Cell Lung Cancer
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01017133
UPCC 01509
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP