BRIGHT-CEA: Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01873716

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Atherosclerotic Plaque Carotid Stenosis	Drug: Indocyanine green	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Arm

Intervention/Treatment

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Tissue uptake of indocyanine green in carotid plaque [within 3 months after carotid endarterectomy]
Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy

Secondary Outcome Measures

Relationship of indocyanine green uptake to carotid plaque histology [within 3 months after carotid endarterectomy]
Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consecutive patients scheduled for elective carotid endarterectomy at Massachusetts General Hospital
Age > 18 years of age.
Signed informed consent.

Exclusion criteria:

Hemodynamic instability
Any history of iodide allergy
Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) <50 ml/min/1.73 m2)
Any history of liver failure
Any history of bleeding diathesis
Any history of cerebral vascular accident in the preceding 3 months
Pregnant or lactating females.
Hx of seafood allergy