AtherosclerosisPhase 1BRIGHT-CEANCT01873716
Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque
A Phase 1 study testing Indocyanine green in people with Atherosclerosis and Atherosclerotic Plaque, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Atherosclerotic Plaque, Carotid Stenosis
- What is being tested?
- Indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients scheduled for elective carotid endarterectomy at Massachusetts General Hospital
- Age > 18 years of age.
- Signed informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Conditions
- Atherosclerosis, Atherosclerotic Plaque, Carotid Stenosis
- Being tested
- Indocyanine green
- Keywords
- Atherosclerosis, Molecular Imaging, Vascular Biology, Inflammation, Fluorescence
- Medical subject headings
- Atherosclerosis, Plaque, Atherosclerotic, Carotid Stenosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Also called FDA Application No. (ANDA) 040811
Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy
| Study group | Role | What they receive |
|---|---|---|
| Injection of Indocyanine Green | Experimental | Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis. Receives: Drug: Indocyanine green |
| No injection | No intervention | No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 3 months after carotid endarterectomy
Secondary outcomes (1)
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
Measured: within 3 months after carotid endarterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farouc Amin Jaffer, Massachusetts General Hospital
- Investigators
- Farouc A Jaffer, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873716
- Sponsor's protocol ID
- 2012P000895
- Acronym
- BRIGHT-CEA
- Status last verified
- Jan 2017
- First submitted
- 23 May 2013
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21613624Verjans 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.
PubMed 27544892
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study
- ClinicalTrials.gov ID
- NCT01873716
- Acronym / sponsor ID
- BRIGHT-CEA / 2012P000895
- Conditions
- Atherosclerosis, Atherosclerotic Plaque, Carotid Stenosis
- Keywords
- Atherosclerosis, Molecular Imaging, Vascular Biology, Inflammation, Fluorescence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection of Indocyanine Green | Experimental | Drug: Indocyanine greenInjection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis. |
| No injection | No intervention | –No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients scheduled for elective carotid endarterectomy at Massachusetts General Hospital
- Age > 18 years of age.
- Signed informed consent.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine greenAlso: FDA Application No. (ANDA) 040811Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy | Drug | Injection of Indocyanine Green |
Primary outcome
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
1 secondary outcome
Relationship of indocyanine green uptake to carotid plaque histology
Time frame: within 3 months after carotid endarterectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Background: PubMed 21613624Vinegoni 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.
- Derived from this study: PubMed 27544892Verjans 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farouc A Jaffer, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indocyanine green in people with Atherosclerosis and Atherosclerotic Plaque, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue uptake of indocyanine green in carotid plaque (time frame: within 3 months after carotid endarterectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.