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New PET tracer could spot hidden heart nerve damage in ICD patients

NCT ID NCT06965621

Diagnosis Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This phase 2 study tests a new radioactive imaging agent, 18F-mFBG, to measure nerve damage in the hearts of 20 people with stable heart failure and implantable defibrillators (ICDs). The goal is to see if the agent can reveal differences in nerve function between those who have had a shock from their ICD and those who have not. The study will also compare the new agent to existing imaging methods and check for side effects.

What this could mean

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

Active substance
18F-metaFluorobenzylguanidine (18F-mFBG)
What this could lead to
If successful, this imaging method could help doctors better identify which heart failure patients are at risk of dangerous heart rhythms, potentially improving ICD therapy decisions.
What could go wrong
This is a small, early-phase study (20 people) focused on imaging, not treatment. The new agent may not prove better than existing methods, and safety data are still being collected.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Stable heart failure from ischemic cardiomyopathy, LVEF \< or = 35%, ICD implantation for at least 12 months Exclusion Criteria: * Unstable coronary artery disease, no ICD implantation

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Conditions

The condition(s) this trial relates to.

cardiomyopathy dilated cardiomyopathy heart failure impulse control disorder myocardial ischemia

As listed by the trial registrant

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

Heart failure Icd patients Ischemic cardiomyopathy

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

  • UT Health Houston

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

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