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

Mass General Brigham

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Peripheral Arterial Disease; Carotid Artery Diseases

Treatments: Other: Placebo; Drug: Pegulicianine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06957821

2024P002945

5R01HL165453-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Active inflammation plays a key role in causing Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). Since inflammation is so important in how these diseases start, are diagnosed, and treated, being able to see it clearly in each patient could lead to more personalized and effective care - and may help prevent heart attacks. Right now, there's no imaging technology available to clearly see inflammation inside the coronary arteries.

We hope to learn how an imaging drug; called LUMISIGHT (Pegulicianine) can help detect inflammation in blood vessels compared with saline, a harmless saltwater solution. If we find out that LUMISIGHT is active in humans, we might be able to use it for detecting plaque risk in the future.

Full description

Objective of this research is to find out if a special imaging drug called LUMISIGHT can show inflammation inside blood vessels for subjects with severe coronary and peripheral arterial disease. This will allow us to obtain information about diseases that cause inflammation in the heart and blood vessels.

On the day of the procedure, at least 2 hours before the surgery, subjects will be injected with either the LUMISIGHT or saline. Following the injection, subjects will be monitored and observed for 30 minutes for any allergic reaction. Subjects will then undergo the standard of care surgery. During the procedure, surgeon will take out blocked pieces of subjects' blood vessel for clinical care. We will get these discarded pieces and image it with a special imaging system developed by the Tearney Lab. This system uses a thin tube with a light-based camera (called OCT-NIRF) to capture detailed images.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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25 participants in 2 patient groups, including a placebo group

PEGULICIANINE (LUMISIGHT)

Experimental group

Description:

Twenty (20) subjects will receive 1.0 mg/kg of LUMISIGHT

Treatment:

Drug: Pegulicianine

Normal Saline

Placebo Comparator group

Description:

Five(5) subjects will receive saline injections and be considered controls

Treatment:

Other: Placebo