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Pharmacokinetic and Radiation Dosimetry Study Evaluating 99m TC-EC-DG SPECT/CT in Patients With Non-small Cell Lung Cancer (NSCLC)

NCT00864110 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2013-03-22

No results posted yet for this study

Summary

This is a multi-center Phase 1 b study designed to expand the patient safety using 99mTc-EC-DG with SPECT/CT imaging and to expand the patient radiation dosimetry and pharmacokinetic database using 99mTc-EC-DG in patients who have non-incisional biopsy definitive evidence of Non-small Cell Lung Cancer as compared to 18F-FDG PET/CT imaging.

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 20 mCi (range 20-30 mCi) to be given by slow IV push (over 3-5 minutes) 1mg of EC-DG will be injected

RADIATION

Technetium 99m ethylenedicysteine-deoxyglucose

99mTc EC-DG injection, single dose, slow IV push over 3-5 minutes, yielding a target activity of 20 mCi (range 20-30 mCi)

RADIATION

18 F fluorodeoxyglucose

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

Sponsors & Collaborators

  • Numoda

    collaborator INDUSTRY

  • Venn Life Sciences

    collaborator OTHER

  • Camargo Pharmaceutical Services

    collaborator INDUSTRY

  • Biomedical Systems

    collaborator INDUSTRY

  • 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
2010-04-30
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • United States

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 NCT00864110 on ClinicalTrials.gov