New PET tracer aims to reveal hidden heart nerve damage
NCT ID NCT04535193
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
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Nov 2021
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Mount Sinai Morningside
New York, New York, 10025, United States
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