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Glow-in-the-Dark dye could reveal hidden heart attack risk

NCT ID NCT06957821

Diagnosis Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests whether a fluorescent dye called LUMISIGHT (pegulicianine) can light up inflammation in artery plaques removed during surgery. Inflammation is a key driver of heart attacks, but current imaging can't see it clearly. Researchers will compare the dye to a placebo in 25 people with severe carotid or peripheral artery disease. If the dye works, it might one day help doctors identify high-risk plaques before they cause problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pegulicianine (LUMISIGHT) dye
What this could lead to
If successful, this could lead to a new way to see dangerous inflammation in arteries, helping doctors better predict and prevent heart attacks.
What could go wrong
This is a very early, small study (25 people) testing the dye on removed tissue, not in living patients. It may not work as hoped or translate to real-time imaging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

carotid artery disorder peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carotid artery diseases Peripheral arterial disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.