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

Study Description

Brief 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.

Detailed Description: Male and female patients at least 18 years old with untreated Non-small Cell Lung Cancer who have non-incisional biopsy definitive evidence of disease (or cytology results from a bronchoscope procedure confirming NSCLC) 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 99mTc-EC-DG with SPECT/CT(if the PET/CT was performed as part of the pre-study activities on a qualified PET camera for this study, the SPECT/CT must be done within 45 days of the PET/CT imaging procedures). The study procedures can be performed within 5-7 days of signing the informed consent. During the 99mTc-EC-DG SPECT/CT visit of the study, pharmacokinetic (PK) blood draws and urine collection will be taken and radiation dosimetry (Planar Imaging) will be performed at specified time points post 99mTc-EC-DG injection. Patients will be seen 24 hours after the 99mTc-EC-DG injection for safety and final PK blood and urine collection. 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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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