Status:
NOT_YET_RECRUITING
Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Carotid Artery Diseases
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06957821
Start Date
October 30 2025
End Date
December 31 2027
Last Update
October 22 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114