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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: Completed Phase 1 study of Atherosclerosis and Carotid Stenosis, sponsored by Massachusetts General Hospital.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy

Interventions

  • DRUG Indocyanine green

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2013-05
Est. Completion 2016-01
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT01873716 record still lists

NCT01873716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,066-participant average among 69 other Atherosclerosis trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Similar trials for Atherosclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01873716's enrollment target sits among peer trials

5 70th of 69 the lowest of 69 other Atherosclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Atherosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01873716, the US trial registry maintained by the National Library of Medicine. NCT01873716 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.