NCT01873716

Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis
• Atherosclerotic Plaque
• Carotid Stenosis

Interventions

Type	Name	Description
DRUG	Indocyanine green	Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-06-10
• Last updated: 2017-02-02

Locations

1 site across 1 country: United States