Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

Overview

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.

Full Title of Study: “Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque — A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Injection of Indocyanine Green
    • Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.
  • No Intervention: No injection
    • No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Farouc Amin Jaffer, Associate Professor of Medicine, Harvard Medical School – Massachusetts General Hospital
  • Overall Official(s)
    • Farouc A Jaffer, MD PhD, Principal Investigator, Massachusetts General Hospital

References

Vinegoni C, Botnaru I, Aikawa E, Calfon MA, Iwamoto Y, Folco EJ, Ntziachristos V, Weissleder R, Libby P, Jaffer FA. Indocyanine green enables near-infrared fluorescence imaging of lipid-rich, inflamed atherosclerotic plaques. Sci Transl Med. 2011 May 25;3(84):84ra45. doi: 10.1126/scitranslmed.3001577.

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