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

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special imaging drug called LUMISIGHT (Pegulicianine) to see if it can help detect inflammation in blood vessels, which is important for understanding conditions like Carotid Artery Disease and Peripheral Arterial Disease. Inflammation plays a big role in these diseases, and being able to see it clearly can lead to better, more tailored treatment for patients. Right now, there isn't a way to visualize this inflammation in coronary arteries, so this study aims to find out if LUMISIGHT can fill that gap by comparing it with a harmless saltwater solution.

To take part in this trial, participants need to be at least 18 years old and have been diagnosed with severe carotid or peripheral arterial disease that requires surgery. They must also be healthy enough to undergo the procedure and able to provide informed consent. If you join the study, you'll receive the imaging agent and be monitored to see how well it works in detecting inflammation. It's important to note that some people, like those with certain allergies, serious health issues, or specific blood pressure levels, may not be eligible. This study is not yet recruiting participants, but it represents an exciting step toward improving care for heart and blood vessel conditions.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • History of allergic reaction to oral or intravenous contrast agents
• • History of allergic reaction to polyethylene glycol (PEG)
• • History of allergic or anaphylactic reactions
• • Patients who have taken an investigational drug within 14 days of enrollment.
• • Patients with hemodynamic instability
• • Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) \<60ml/min/1.73 m2)
• • Pregnant or lactating females
• • Patients 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