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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Radiation: fludeoxyglucose F 18
Radiation: Fluorine F 18 EF5
Procedure: Positron emission tomography
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects With Non-Small Cell Lung Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 56
Study Start Date: May 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017133

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01017133     History of Changes
Other Study ID Numbers: UPCC 01509
Study First Received: November 18, 2009
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Deoxyglucose
 Fluorides
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013