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

NCT06957821 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DRUG

Pegulicianine

Pegulicianine (LUMISIGHT) Inflammatory activity

OTHER

Placebo

Control group for the study

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Guillermo Tearney, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-07-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06957821 on ClinicalTrials.gov