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New PET tracer aims to reveal hidden heart nerve damage

NCT ID NCT04535193

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This early-phase trial tests a radioactive imaging agent called 18F-mFBG to see how well it can show the nerves in the heart. Researchers will give the agent to 10 adults—some with heart disease and some without—and take PET scans over time. The goal is to measure how the agent moves through the body and heart, and to see if it can spot areas of nerve damage in people with weak heart pumps.

What this could mean

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

Active substance
18F-mFBG (a radioactive imaging agent)
What this could lead to
If successful, this could provide a new way to detect and measure nerve damage in the heart, helping doctors diagnose and manage heart disease earlier.
What could go wrong
This is a very early, small study (10 people) focused on imaging, not treatment. The agent may not clearly show nerve damage, or results may not apply to broader populations.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

10 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Aug 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

Accepted

You do not need to have the condition being studied to take part.

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: * ≥ 18 years of age at study entry * able and willing to comply with study procedures * signed and dated informed consent is obtained * male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative. For control subjects: * Subject is either: * \<40 years old and has a likelihood assessment for CAD \<10%, or * 40-50 years old, has a likelihood assessment for CAD \<10%, and a normal stress MPI study or stress echocardiography performed within 6 months before study entry, or * Without significant coronary atherosclerotic disease (no arterial stenosis with \>30% narrowing) as demonstrated by a coronary angiography performed with 6 months before study entry. For heart failure subjects: * Diagnosed with HF at least 1 year before enrollment. * HF classification NYHA Class II at enrollment. * Rest left ventricular ejection fraction (LVEF) ≤35% measured by an appropriate method (e.g., radionuclide or contrast ventriculography, ECG-gated SPECT MPI, or echocardiography) within 180 days prior to the study imaging procedure, with no change in clinical condition since the LVEF measurement. * Primary prevention ICD, implanted at least 6 months before enrollment. * Clinically stable for at least 30 days before enrollment (e.g., not experiencing continuing chest pain, hemodynamic instability, or clinically significant arrhythmia (including ICD discharge)) and remains stable to the time of the study imaging procedure. Exclusion Criteria: * Previously entered into this study or has participated in any other investigational medicinal product or medical device study within 30 days of enrollment. * History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent. * Ventricular pacemaker that routinely functions (\>5% paced beats) * Cardiac revascularization (e.g., percutaneous transluminal coronary angioplasty, PCI, or CABG), or an acute myocardial infarction within the past 30 days. * Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study. * Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma. * Claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to an hour at a time. * Renal insufficiency (serum creatinine \>3.0 mg/dL). * Use of medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures. * Participated in a research study using ionizing radiation in the previous 12 months. * For control subjects: a history of Type I or Type II Diabetes Mellitus, signs/symptoms of neurological disease (e.g., Parkinson's Disease, Multiple System Atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mount Sinai Morningside

    New York, New York, 10025, United States

More trials for these conditions

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