Pegulicianine for Peripheral Artery Disease

Overseen By Anita Chung

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Massachusetts General Hospital

Disqualifiers: Renal failure, Uncontrolled hypertension, Severe illnesses, others

Compensation: Varies

Number of Visits: 2

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken an investigational drug in the last 14 days, you cannot participate.

What is the purpose of 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. We hope to learn how an imaging drug; called LUMISIGHT (Pegulicianine) can help detect inflammation in blood vessels compared with saline, a harmless saltwater solution. If we find out that LUMISIGHT is active in humans, we might be able to use it for detecting plaque risk in the future.

Research Team

Guillermo Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals with Peripheral Artery Disease or Carotid Artery Disease who are undergoing surgery to remove artery plaques. Participants must be eligible for the surgical procedure and willing to have their excised tissue examined.

Inclusion Criteria

Must be able to give informed consent

My kidney function is normal or only mildly impaired.

I am capable of becoming pregnant and have a negative pregnancy test.

Exclusion Criteria

History of allergic reaction to polyethylene glycol (PEG)

History of allergic or anaphylactic reactions

History of allergic reaction to oral or intravenous contrast agents

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-procedure

Participants are injected with either LUMISIGHT or saline at least 2 hours before surgery and monitored for allergic reactions

2-6 hours

1 visit (in-person)

Procedure

Standard of care surgery is performed, and excised artery plaques are imaged using OCT-NIRF

Same day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

Treatment Details

Interventions

• Pegulicianine

Trial Overview The study tests a fluorescence imaging agent called Pegulicianine (LUMISIGHT) against a saline placebo. It aims to see if LUMISIGHT can better detect inflammation in blood vessels, which could improve personalized care and prevent heart attacks.

Participant Groups

Group I: PEGULICIANINE (LUMISIGHT) Experimental Treatment 1 Intervention

Twenty (20) subjects will receive 1.0 mg/kg of LUMISIGHT

Group II: Normal Saline Placebo Group 1 Intervention

Five(5) subjects will receive saline injections and be considered controls

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+