Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques (NCT06957821) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
United States25 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Demonstrate lumisight fluorescence activity in lumisight cohort vs controls