Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque (BRIGHT-CEA)
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.
Drug: Indocyanine green
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study|
- Tissue uptake of indocyanine green in carotid plaque [ Time Frame: within 3 months after carotid endarterectomy ] [ Designated as safety issue: No ]Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy
- Relationship of indocyanine green uptake to carotid plaque histology [ Time Frame: within 3 months after carotid endarterectomy ] [ Designated as safety issue: No ]Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology
|Study Start Date:||May 2013|
|Study Completion Date:||January 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Injection of Indocyanine Green
Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.
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
Other Name: FDA Application No. (ANDA) 040811
No Intervention: No injection
No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01873716
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Farouc A Jaffer, MD PhD||Massachusetts General Hospital|