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Not yet recruitingNCT06957821Updated Apr 20, 2026

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

An Early Phase 1 interventional study of Pegulicianine and Placebo in Carotid Artery Diseases and Peripheral Arterial Disease, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

Read the 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.

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Conditions studied

  • Carotid Artery Diseases
  • Peripheral Arterial Disease
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In context

Carotid Artery Diseases

248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.

This study's planned enrollment of 25 is below the median of 120 across 118 interventional studies indexed under Carotid Artery Diseases.

Browse Carotid Artery Diseases studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    PEGULICIANINE (LUMISIGHT)

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

    Drug: Pegulicianine

  • Placebo comparator
    Normal Saline

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

    Other: Placebo

Interventions

  • DrugPegulicianine

    Pegulicianine (LUMISIGHT) Inflammatory activity

    Also known as: LUMISIGHT

  • OtherPlacebo

    Control group for the study

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What researchers measure

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

    Time frame: 2-6 hours

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Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06957821
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Guillermo Tearney (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
May 5, 2025
Start date
Jun 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Apr 20, 2026

Study contacts

Anita Chung
Contact
achung7@mgh.harvard.edu
6177244515
Guillermo Tearney, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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