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.
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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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 10 November 2026