- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01873716
Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque (BRIGHT-CEA)
Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Injection of Indocyanine Green
Injection of Indocyanine Green prior to carotid endarterectomy surgery.
Collection of specimen during surgery with subsequent carotid tissue analysis.
|
Indocyanine green (ICG) for injection, 0.25mg/kg intravenously.
A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy
Other Names:
|
No Intervention: No injection
No injection prior to carotid endarterectomy surgery.
Collection of specimen during surgery with subsequent carotid tissue analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 3 months after carotid endarterectomy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 3 months after carotid endarterectomy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Farouc A Jaffer, MD PhD, Massachusetts General Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Carotid Artery Diseases
- Carotid Stenosis
- Atherosclerosis
- Plaque, Atherosclerotic
Other Study ID Numbers
- 2012P000895
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atherosclerosis
-
University Hospital, CaenUnknownPeripheral Arterial Disease | Atherosclerosis Obliterans | Atherosclerosis Right Leg | Atherosclerosis Left LegFrance
-
Nantes University HospitalAbbottCompletedAtherosclerosis ObliteransFrance
-
Federal University of São PauloCompletedAtherosclerosis of ArteryBrazil
-
Central Hospital, Nancy, FranceSuspended
-
MedtronicActive, not recruitingAtherosclerosis of Femoral Artery | Obstructive Disease | Atherosclerosis of Popliteal ArteryFrance
-
Cabinet de Medecine Interne Générale Demetrio PitarchCompletedAtherosclerosis of Artery
-
Emory UniversityThe Robert W. Woodruff FoundationCompleted
-
Zhejiang Zylox Medical Device Co., Ltd.RecruitingAtherosclerosis of Femoral ArteryGermany
-
VA Office of Research and DevelopmentCompletedSaphenous Vein Graft AtherosclerosisUnited States
-
Korea UniversityMinistry of Health & Welfare, KoreaCompletedAtherosclerosis | Noninvasive Imaging of AtherosclerosisKorea, Republic of
Clinical Trials on Indocyanine green
-
University of PennsylvaniaCompletedIschemic Stroke | Traumatic Brain Injury | Subarachnoid Hemorrhage | Intracerebral Hemorrhage | Acute Anoxic EncephalopathyUnited States
-
Corporacion Parc TauliRecruitingAcute Cholecystitis | Bile Duct InjurySpain
-
Wei ChenEnrolling by invitation
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingOvarian Cancer | Adnexal MassUnited States
-
Shanghai University of Traditional Chinese MedicineUnknownRheumatoid Arthritis | Lymph Node Mass | Lymphatic Vessel; DilatationChina
-
Birmingham Women's and Children's NHS Foundation...Not yet recruitingTracheo-Esophageal Fistula With Atresia of EsophagusUnited Kingdom
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruitingSentinel Lymph NodeTurkey
-
NYU Langone HealthRecruitingRotator Cuff TearsUnited States
-
Rigshospitalet, DenmarkActive, not recruitingGastric CancerDenmark
-
Mayo ClinicWithdrawnGastric CancerUnited States