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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging drug called LUMISIGHT (Pegulicianine) to determine its ability to detect inflammation in blood vessels, which is crucial for understanding and treating Peripheral Artery Disease (PAD). Researchers compare LUMISIGHT to a placebo (a harmless saline solution) to evaluate its effectiveness. This trial may suit individuals with severe PAD who require surgery, but it is not suitable for those with allergies to contrast agents or certain health issues like uncontrolled high blood pressure. As an Early Phase 1 trial, participants have the unique opportunity to be among the first to receive this new treatment, contributing to foundational research on its effects in humans.

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.

Is there any evidence suggesting that Pegulicianine is likely to be safe for humans?

Research has shown that pegulicianine, the treatment under study, did not harm the body's normal functions in earlier safety tests. It did not cause unwanted changes in how the body works. However, studies involving people, particularly those who are pregnant or might become pregnant, have not provided enough information. The FDA has requested more data to fully understand the safety and effectiveness of pegulicianine. Although this treatment remains in the early stages of testing, initial findings suggest it might be well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for Peripheral Artery Disease (PAD) focus on improving blood flow using medications like antiplatelets and statins or through surgical interventions. However, Pegulicianine is unique because it uses a novel active ingredient that may enhance imaging of blood vessels. Researchers are excited about Pegulicianine because it could help in precisely identifying and targeting the affected areas in blood vessels, potentially leading to more effective treatment decisions. This innovative approach might offer a more accurate assessment of the disease, which is a significant step forward from current options.

What evidence suggests that Pegulicianine might be an effective treatment for detecting inflammation in Peripheral Artery Disease?

In this trial, pegulicianine, also known as LUMISIGHT, is under study for its potential to help identify inflammation in blood vessels. Research has shown that pegulicianine can highlight problem areas by illuminating inflamed or abnormal tissues. Although primarily studied for this purpose, earlier research found it effective in detecting early-stage tumors in the digestive system. The goal is for pegulicianine to enhance visibility inside blood vessels, potentially leading to better treatment options for conditions like Peripheral Artery Disease (PAD). While direct data on its use for PAD is limited, its success in other areas is promising. Participants in this trial will receive either pegulicianine or a saline placebo to evaluate its effectiveness in this new application. ^{1 4 5 6 7}

Who Is on the Research Team?

Guillermo Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: PEGULICIANINE (LUMISIGHT) Experimental Treatment 1 Intervention

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

Group II: Normal Saline Placebo Group 1 Intervention

Five(5) participants 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+

Citations

1. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/214511Orig1s000MultidisciplineR.pdf

214511Orig1s000 - accessdata.fda.gov Approximately 63% of patients with stage I or II disease undergo breast-conserving surgery with or without adjuvant radiation therapy and 33% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12048172/

Perspective on the use of fluorescence molecular imaging ... We aim to explore fluorescence molecular imaging (FMI) as a tool for resolving obstacles and integrating PDEMA into the surgeon-to-pathologist workflow for ...

3. mdpi.com mdpi.com/1420-3049/30/3/482

An Analysis of the FDA Drug Approvals from ... The U.S. Food and Drug Administration (FDA) has authorized 50 new drugs in 2024, which matches the average figure for recent years (2018–2023).

4. lumicell.com lumicell.com/lumicell-announces-promising-feasibility-trial-findings-using-pegulicianine-in-gastrointestinal-cancer-patients/

Lumicell Announces Promising Feasibility Trial Findings ... These findings support the use of pegulicianine-fluorescence imaging in detecting early-stage and neoadjuvant-treated gastric tumors.

5. digitalcommons.dartmouth.edu digitalcommons.dartmouth.edu/cgi/viewcontent.cgi?article=1168&context=masters_theses

Preclinical Examination of a Nerve Specific Fluorophore ... A 60-year-old man diagnosed with poorly controlled type II diabetes, occlusive peripheral artery disease, and recent burns to the lower ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/214511s000lbl.pdf

Lumisight - accessdata.fda.gov Risk Summary. There are no available data on pegulicianine use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or ...

7. nature.com nature.com/articles/d41573-025-00001-5

2024 FDA approvals The FDA instead issued a complete response letter, reportedly requesting additional phase III data to assess the safety and efficacy of the drug ...