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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Farouc Amin Jaffer, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01873716
First received: May 23, 2013
Last updated: June 16, 2014
Last verified: June 2014
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Tissue uptake of indocyanine green in carotid plaque [ Time Frame: within 3 months after carotid endarterectomy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology


Estimated Enrollment: 9
Study Start Date: May 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873716

Contacts
Contact: Farouc A Jaffer, MD PhD 617-724-9353 fjaffer@mgh.harvard.edu
Contact: Heather A Marino-Mitchell, MLA 617-643-9325 hamarino@partners.org

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

Publications:
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
Study First Received: May 23, 2013
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Atherosclerosis
Molecular Imaging
Vascular Biology
Inflammation
Fluorescence

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

ClinicalTrials.gov processed this record on September 18, 2014