An Early Phase 1 interventional study of Pegulicianine and Placebo in Carotid Artery Diseases and Peripheral Arterial Disease, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Other
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.
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 then undergo the standard of care surgery for their clinical care. During the procedure, surgeon will take out blocked pieces of subjects' blood vessel for clinical care. The investigators will get these discarded pieces and image it with a special imaging system developed by the Tearney Lab. This system uses a thin tube with a light-based camera (called Optical Coherence Tomography-Near Infra Red Fluorescence or OCT-NIRF) to capture detailed images.
248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.
This study's planned enrollment of 25 is below the median of 120 across 118 interventional studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Twenty (20) participants will receive 1.0 mg/kg of LUMISIGHT
Drug: Pegulicianine
Five(5) participants will receive saline injections and be considered controls
Other: Placebo
Pegulicianine (LUMISIGHT) Inflammatory activity
Also known as: LUMISIGHT
Control group for the study
Demonstrate lumisight fluorescence activity in lumisight cohort vs controls
Mean difference in plaque for fluorescence ratio to show that fluorescence in the Lumisight cohort is 2 fold greater than that of the control
Time frame: 2-6 hours
Plan to share: No
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Massachusetts General Hospital