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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01873716
First Posted: June 10, 2013
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Farouc Amin Jaffer, Massachusetts General Hospital
  Purpose

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 Intervention Phase
Atherosclerosis Atherosclerotic Plaque Carotid Stenosis Drug: Indocyanine green Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Farouc Amin Jaffer, Massachusetts General Hospital:

Primary Outcome 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 Outcome 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


Enrollment: 5
Study Start Date: May 2013
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873716


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Farouc A Jaffer, MD PhD Massachusetts General Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Farouc Amin Jaffer, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01873716     History of Changes
Other Study ID Numbers: 2012P000895
First Submitted: May 23, 2013
First Posted: June 10, 2013
Last Update Posted: February 2, 2017
Last Verified: January 2017

Keywords provided by Farouc Amin Jaffer, Massachusetts General Hospital:
Atherosclerosis
Molecular Imaging
Vascular Biology
Inflammation
Fluorescence

Additional relevant MeSH terms:
Atherosclerosis
Carotid Stenosis
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical