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.
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. \[An actual patient visit is NOT required at the 21-day follow-up time point.\]
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
22
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
single injection of 18F FDG (range 10-20mCi)
Baptist Health South Florida
Coral Gables, Florida, United States
Decatur Memorial Hospital Department of Radiology
Decatur, Illinois, United States
John Hopkins University
Baltimore, Maryland, United States
Mayo Clinic, Division of Nuclear Medicine
Rochester, Minnesota, United States
Safety: Through adverse event collection
Time frame: from 99m Tc-Ec-DG injection through 21 days
Efficacy: Comparison of 18F FDG PET/CT image against 99m Tc-EC-DG image
Time frame: End of study
Efficacy: determine comparability of diagnostic information between SPECT (acs) and SPECT/CT (als) imaging
Time frame: End of Study
Efficacy: To provide evidence of 99m Tc-Ec-DG in identifying anatomical regions with known Non-small cell lung cancer and in determining extent of disease in these patients as compared to 18F-FDG PET/CT imaging
Time frame: End of Study
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Montefiore Medical Center, Department of Nuclear Medicine
The Bronx, New York, United States
Lions Gate Hospital
North Vancouver, British Columbia, Canada