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

Primary Purpose

Atherosclerosis, Atherosclerotic Plaque, Carotid Stenosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atherosclerosis focused on measuring Atherosclerosis, Molecular Imaging, Vascular Biology, Inflammation, Fluorescence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Injection of Indocyanine Green

No injection

Arm Description

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

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

Outcomes

Primary Outcome Measures

Tissue uptake of indocyanine green in carotid plaque
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
Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology

Full Information

First Posted
May 23, 2013
Last Updated
January 31, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01873716
Brief Title
Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque
Acronym
BRIGHT-CEA
Official Title
Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Atherosclerotic Plaque, Carotid Stenosis
Keywords
Atherosclerosis, Molecular Imaging, Vascular Biology, Inflammation, Fluorescence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection of Indocyanine Green
Arm Type
Experimental
Arm Description
Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.
Arm Title
No injection
Arm Type
No Intervention
Arm Description
No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
FDA Application No. (ANDA) 040811
Intervention Description
Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy
Primary Outcome Measure Information:
Title
Tissue uptake of indocyanine green in carotid plaque
Description
Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy
Time Frame
within 3 months after carotid endarterectomy
Secondary Outcome Measure Information:
Title
Relationship of indocyanine green uptake to carotid plaque histology
Description
Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology
Time Frame
within 3 months after carotid endarterectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farouc A Jaffer, MD PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21613624
Citation
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.
Results Reference
background
PubMed Identifier
27544892
Citation
Verjans JW, Osborn EA, Ughi GJ, Calfon Press MA, Hamidi E, Antoniadis AP, Papafaklis MI, Conrad MF, Libby P, Stone PH, Cambria RP, Tearney GJ, Jaffer FA. Targeted Near-Infrared Fluorescence Imaging of Atherosclerosis: Clinical and Intracoronary Evaluation of Indocyanine Green. JACC Cardiovasc Imaging. 2016 Sep;9(9):1087-1095. doi: 10.1016/j.jcmg.2016.01.034. Epub 2016 Aug 17.
Results Reference
derived

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Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

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