Health TrialsbyHealthPanel

Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques

ConditionsCarotid Artery DiseasesPeripheral Arterial Disease
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pegulicianine

    Drug

    Pegulicianine (LUMISIGHT) Inflammatory activity

  • Placebo

    Other intervention

    Control group for the study

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: PEGULICIANINE (LUMISIGHT)Experimental treatment 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: