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Not yet taking people in United StatesEarly phase 1

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

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Status
Not yet recruiting
Phase
Early phase 1
People taking part
25 people, planned
Starts
Jun 2027
Expected to end
Dec 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Pegulicianine
  • Placebo
Record updated
10 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participants who have taken an investigational drug within 14 days of enrollment
  • 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
  • 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 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
  • Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) <60ml/min/1.73 m2)
  • Participants with hemodynamic instability
  • Pregnant or lactating females

Where in United States

  • Massachusetts General HospitalBoston, United StatesContact: Anita ChungNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • PEGULICIANINE (LUMISIGHT)Treatment being tested

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

    Treatment: Pegulicianine

  • Normal SalinePlacebo, for comparison

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

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
10 November 2026