NCT00865319

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

A Multicenter Phase 2 Study Comparing 99m Tc EC-DG SPECT/CT With 18F FDG PET/CT in the Evaluation of Patients With Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cell>Point LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Male and female patients at least 18 years of age with untreated Non-small Cell Lung Cancer who have non-incisional biopsy definitive evidence of disease (or from cytology results from a bronchoscope procedure) and who have been previously certified (per centers for Medicare and Medicaid Services requirements) by their physicians will be consented for the study. The study consists of a screening visit, gold-standard 18F-FDG PET/CT imaging followed by the investigational agent 99m Tc-Ec-DG SPECT/CT. The study procedures can be performed within 5-7 days of signing the informed consent. \[To better meet the standard of care at each clinical location, the PET/CT can be performed as part of pre-study procedures on a PET/CT camera previously qualified by the site to meet the standards required for the study. If this occurs, the SPECT/CT must be performed within 45 days of the PET/CT imaging procedures.\] Patients will be seen 24 hours after the 99m Tc-Ec-DG injection for safety. A 21-day follow-up period (after the SPECT/CT image) will allow the investigator to acquire additional imaging, surgical, pathology and treatment documentation. \[An actual patient visit is NOT required at the 21-day follow-up time point.\]

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2009-03-19
• Last updated: 2013-03-22

Locations

6 sites across 2 countries: United States, Canada