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

NCT ID: NCT06957821

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-12-31

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 participants 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.

Conditions

Carotid Artery Diseases; Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

PEGULICIANINE (LUMISIGHT)

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

Group Type: EXPERIMENTAL

Pegulicianine

Intervention Type: DRUG

Pegulicianine (LUMISIGHT) Inflammatory activity

Normal Saline

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Control group for the study

Interventions

Pegulicianine

Pegulicianine (LUMISIGHT) Inflammatory activity

Intervention Type: DRUG

Placebo

Control group for the study

Intervention Type: OTHER

Other Intervention Names

LUMISIGHT

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Tearney

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Tearney, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Anita Chung

Role: CONTACT

achung7@mgh.harvard.edu

6177244515

Facility Contacts

Anita Chung

Role: primary

achung7@mgh.harvard.edu

6177244515

Other Identifiers

5R01HL165453-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024P002945

Identifier Type: -

Identifier Source: org_study_id