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

Mass General Brigham

Status and phase: Completed; Phase 1

Conditions: Carotid Stenosis; Atherosclerosis; Atherosclerotic Plaque

Treatments: Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT01873716

2012P000895

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 2 patient groups

Injection of Indocyanine Green

Experimental group

Description:

Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.

Treatment:

Drug: Indocyanine green

No injection

No Intervention group

Description:

No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.