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Phase 2 Study Comparing 99mTc-EC-DG SPECT/CT With 18F FDG PET/CT in Patients With Non-small Cell Lung Cancer (NSCLC)

NCT00865319 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-03-22

No results posted yet for this study

Summary

This is a multiple-center Phase 2 study designed to expand the patient safety and clinical information using 99m Tc-Ec-DG with Spect/CT imaging, to develop procedures and methods for evaluation of the imaging studies, to determine comparability of diagnostic information between SPECT and SPECT/CT imaging and to to compare the safety and efficacy of 99m Tc-EC-DG SPECT/CT with 18F-FDG PET/CT in imaging patients with biopsy confirmed diagnosis of Non-small Cell Lung Cancer.

Conditions

  • Non Small Cell Lung Cancer

Interventions

RADIATION

Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose)

one injection of Technetium ethylenedicysteine-deoxyglucose to yield a target activity of 20mCi (range 20-30 mCi) to be given by slow IV push (over 3-5 minutes) 1mg of EC-DG to be injected

RADIATION

18 F fluorodeoxyglucose

single injection of 18F FDG (range 10-20mCi)

Sponsors & Collaborators

  • Numoda

    collaborator INDUSTRY

  • Venn Life Sciences

    collaborator OTHER

  • Camargo Pharmaceutical Services

    collaborator INDUSTRY

  • Biomedical Services

    collaborator UNKNOWN

  • Cell>Point LLC

    lead INDUSTRY

Principal Investigators

  • Donald Blaufox, MD · Albert Einstein University, Montefiore Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865319 on ClinicalTrials.gov