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

Early Phase 1

Not yet recruiting

• Conditions: Carotid Artery Diseases; Peripheral Arterial Disease
• Interventions: Drug: Pegulicianine; Other: Placebo

• Registration Number: NCT06957821
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

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

Detailed Description

Objective of this research is to find out if a new 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, consented study participants will be injected with either the LUMISIGHT or saline. Following the injection, study participants will be monitored and observed for 30 minutes for any allergic reactions. Study participants will then undergo the standard of care surgery for their clinical care. During the procedure, surgeon will take out blocked pieces of subjects' blood vessel for clinical care. The investigators 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 Optical Coherence Tomography-Near Infra Red Fluorescence or OCT-NIRF) to capture detailed images.

Study Timeline

• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-02
• Study First Posted: 2025-05-05
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-17
• Study Start: 2025-07-30
• Primary Completion: 2027-07-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEGULICIANINE (LUMISIGHT)	Pegulicianine	Twenty (20) subjects will receive 1.0 mg/kg of LUMISIGHT
Normal Saline	Placebo	Five(5) subjects will receive saline injections and be considered controls

Primary Outcome Measures

Name	Time	Method
Demonstrate lumisight fluorescence activity in lumisight cohort vs controls	2-6 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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States