drugset / Trial / NCT01873716

Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

NCT01873716

Phase 1 Completed 5 enrolled Massachusetts General Hospital
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

This will be a pilot study of 9 patients undergoing standard-of-care clinically indicated carotid endarterectomy. The nine patients will receive an injection of Indocyanine green (ICG) at a dose of 0.25 mg/kg (maximum 25 mg) as an intravenous bolus. Immediately following endarterectomy, the resected specimen will be immersed in normal saline. Ex vivo fluorescence reflectance imaging (FRI) and immunohistochemistry will be performed. The investigators hypothesize that compared to controls, ICG-injected patients will demonstrate increased ex vivo and microscopic ICG fluorescence signal within areas of plaque.

Timeline

Start
2013-05
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 0.25 mg/kg Intravenous