Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pegulicianine
- Placebo
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov