This is a proof-of-concept study designed to confirm that human phagocytic cells can be labeled with the near-infrared dye indocyanine green (ICG) and the presence of the labeled cells 48 hours later in cerebral cortex can be inferred using near infrared spectroscopy (NIRS).
Age range
21 Years – 90 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Treatment Emergent Adverse Events (TEAEs)
Timeframe: Dosing (Day 0) through Telephone Follow-up (Day 16)
Electrocardiogram Results
Timeframe: Screening, Day 0 and Day 2
Mean ICG Concentrations
Timeframe: Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours
Mean ICG Concentrations With Full Ranges (Post Hoc Analysis)
Timeframe: Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hour
Change in Percentage (%) Labeling of Peripheral Blood Mononuclear Cells (PBMCs) Labeled With ICG
Timeframe: Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)
Change in Percentage (%) Labeling of Peripheral Blood Mononuclear Cells (PBMCs) Labeled With ICG (Post Hoc Analysis)
Timeframe: Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)
Near-infrared Spectroscopy (NIRS) Measures
Timeframe: Percentage change in NIR-L absorbance was measured at 60 mins. 120 mins, 150 mins, 240 mins and 48 hours after the start of the ICG infusion.
Near-infrared Spectroscopy (NIRS) Measures (Post-hoc Analysis)
Timeframe: Percentage change in NIR-L absorbance was measured at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours after the start of infusion