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

NCT06957821 | Not Yet Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 2024P0029455R01HL165453-03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Diseases; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Demonstrate lumisight fluorescence activity in lumisight cohort vs controls

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

  2-6 hours

Study Arms (2)

PEGULICIANINE (LUMISIGHT)

EXPERIMENTAL

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

Drug: Pegulicianine

Normal Saline

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Pegulicianine DRUG

Pegulicianine (LUMISIGHT) Inflammatory activity

Also known as: LUMISIGHT

PEGULICIANINE (LUMISIGHT)

Placebo OTHER

Control group for the study

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• Guillermo Tearney, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Chung

CONTACT

6177244515; achung7@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 5, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)