Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque (BRIGHT-CEA)
|ClinicalTrials.gov Identifier: NCT01873716|
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : February 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis Atherosclerotic Plaque Carotid Stenosis||Drug: Indocyanine green||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study|
|Study Start Date :||May 2013|
|Primary Completion Date :||January 2016|
|Study Completion Date :||January 2016|
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.
- Tissue uptake of indocyanine green in carotid plaque [ Time Frame: within 3 months after carotid endarterectomy ]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 ]Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873716
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Farouc A Jaffer, MD PhD||Massachusetts General Hospital|