Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01873716

Acronym

BRIGHT-CEA

Enrollment

Registered

2013-06-10

Start date

2013-05-31

Completion date

2016-01-31

Last updated

2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Atherosclerotic Plaque, Carotid Stenosis

Keywords

Atherosclerosis, Molecular Imaging, Vascular Biology, Inflammation, Fluorescence

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.

Interventions

DRUGIndocyanine green

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026