NCT01017133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

November 18, 2009

Last Update Submit

September 25, 2012

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

  • P-Akt in tumor cells as assessed by immunohistochemistry

  • Tumor hypoxia as assessed by 18F-EF5 PET imaging

  • Tumor Glycolysis as assessed by 18F-FDG PET imaging

  • Progression-free survival

  • Overall survival

  • Toxicity assessed by CTCAE v3.0

Study Arms (1)

Arm I

OTHER

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 18Radiation: Fluorine F 18 EF5Procedure: Positron emission tomography

Interventions

fludeoxyglucose F 18RADIATION

Given IV

Also known as: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F18
Arm I
Fluorine F 18 EF5RADIATION

Given IV

Also known as: 18F-EF5
Arm I
Positron emission tomographyPROCEDURE

Undergo scan

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Fluorodeoxyglucose F18Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 20, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

US(1)