Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
Massachusetts General Hospital
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.
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 t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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: * History of allergic reaction to oral or intravenous contrast agents * History of allergic reaction to polyethylene glycol (PEG) * History of allergic…
Interventions
- DrugPegulicianine
Pegulicianine (LUMISIGHT) Inflammatory activity
- OtherPlacebo
Control group for the study
Location
- Massachusetts General HospitalBoston, Massachusetts