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NCT01873716 · ClinicalTrials.gov registry record · Phase 1
Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque
A Phase 1 study of Atherosclerosis and Carotid Stenosis, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT01873716 is a Phase 1 study of Atherosclerosis and Carotid Stenosis that has completed, run by Massachusetts General Hospital. The registered enrollment target is 5 participants, below the 1,066-participant average among 69 other Atherosclerosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01873716, a Phase 1 study of Atherosclerosis and Carotid Stenosis, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Indocyanine green
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01873716
The ClinicalTrials.gov registry entry for NCT01873716 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,066-participant average among 69 other Atherosclerosis trials with a reported enrollment target (100% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Atherosclerosis appearing as the primary indexed condition, and to 1 intervention - of which Indocyanine green is the first listed.
NCT01873716 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01873716 about?
NCT01873716 is a clinical study titled "Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque". 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 resecte...
What is the current status of trial NCT01873716?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2013-05. Estimated completion is 2016-01.
What conditions does trial NCT01873716 study?
This clinical trial studies the following conditions: Atherosclerosis, Carotid Stenosis, Atherosclerotic Plaque.
What interventions are being tested in trial NCT01873716?
The interventions under investigation include: Indocyanine green (DRUG).
Who is sponsoring clinical trial NCT01873716?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01873716 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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