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Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects With Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

P-Akt in tumor cells as assessed by immunohistochemistry

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

UPCC 01509

NCT ID:

NCT01017133

Start Date:

May 2009

Completion Date:

September 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283