What this study is
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.
What's being tested
- Pegulicianine
Intervention · DRUG
Pegulicianine (LUMISIGHT) Inflammatory activity
- Placebo
Intervention · OTHER
Control group for the study
Study details
- Sponsor
- Massachusetts General Hospital
- Conditions
- Carotid Artery Diseases · Peripheral Arterial Disease
- Enrolling
- 25 people
- Starts
- 2026-06
- Est. completion
- 2029-12
- Design
- Single-blind, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Anita Chung · Contact6177244515achung7@mgh.harvard.edu
Study team
Sponsor
Massachusetts General Hospital
Study ID 2024P002945
Principal investigator
Guillermo Tearney, MD, PhD
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.