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Imaging Inflammation in Artery Plaques with Pegulicianine

This study is looking at how a special imaging drug called Pegulicianine (LUMISIGHT) can help doctors see inflammation in blood vessels. Inflammation plays a big role in conditions like carotid artery disease and peripheral arterial disease. Currently, there isn't a good way to clearly see this inflammation. Researchers want to see if LUMISIGHT can highlight inflammation in pieces of artery removed during surgery, compared to a control group receiving saline. If successful, this could lead to better ways to detect plaque risk and personalize care. You might be able to join if you are 18 or older, have severe carotid or peripheral arterial disease requiring surgery, and have a healthy kidney function (estimated glomerular filtration rate ≥ 60 mL/min). The study aims to show LUMISIGHT's activity within 2-6 hours of injection. The current status of this study is unclear.

Study design
This is an interventional study involving 25 participants. It compares the imaging drug Pegulicianine to a placebo (saline).
What's involved
On the day of your surgery, you would receive an injection of either Pegulicianine or saline at least 2 hours beforehand. You would be monitored for 30 minutes for any allergic reactions, and then undergo your standard surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of the study is measured at 2-6 hours after injection.

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NCT06957821

Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques

Not Yet Recruiting
EARLY_PHASE1Ages 18+Interventional
Massachusetts General Hospital
~25 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:PegulicianinePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstrate lumisight fluorescence activity in lumisight cohort vs controls
Measured over 2-6 hours

Conditions

Carotid Artery Diseases
Peripheral Arterial Disease

Explore related trials

Carotid Artery DisorderPeripheral Artery Disease

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Guillermo Tearney, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Anita Chung
[email protected]
6177244515
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must have an established diagnosis of severe carotid or peripheral arterial disease (ischemic or aneurysmal) requiring surgery and be sufficiently healthy to undergo surgery
Must be age of 18 years or older
Must be able to give informed consent
Women with childbearing potential must have a negative pregnancy test
Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 (mild renal impairment

Exclusion

History of allergic reaction to oral or intravenous contrast agents
History of allergic reaction to polyethylene glycol (PEG)
History of allergic or anaphylactic reactions
Participants who have taken an investigational drug within 14 days of enrollment.
Participants with hemodynamic instability
Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) \<60ml/min/1.73 m2)
Pregnant or lactating females
Participants with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
Severe concurrent illnesses including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements

What this trial measures

  • Demonstrate lumisight fluorescence activity in lumisight cohort vs controls2-6 hours

    Mean difference in plaque for fluorescence ratio to show that fluorescence in the Lumisight cohort is 2 fold greater than that of the control