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Cardiovascular DiseasesPhase 1/2NCT04535193

Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation

A Phase 1/2 study testing 18F-mFBG for intravenous administration in people with Cardiovascular Diseases, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 1/2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
18F-mFBG for intravenous administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
5 Nov 2021to 30 Aug 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥ 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:
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  • <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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mount Sinai Morningside

    New York, New York, 10025

Other trials in United States

About this study

Official title: An Open-Label, Exploratory, Phase 1/2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects Without and With Heart Disease

This is a Phase 1/2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.

Read the detailed description

This is a Phase 1/2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The first part of the study will examine control subjects, patients with very low likelihood of coronary heart disease. This initial part will determine optimal imaging procedures for studying uptake and clearance of 18F-mFBG in myocardial sympathetic neurons and provide preliminary data for estimating radiation dosimetry in adults and developing reference files for quantification of normal and abnormal levels of the radiopharmaceutical. The second part will examine a group of stable patients with New York Heart Association (NYHA) class 2 heart failure (HF) and reduced left ventricular (LV) systolic function (LV ejection fraction (EF) ≤35%). The primary objectives of the second part will be to:

  • document the degree to which 18F-mFBG uptake in the heart is reduced and
  • characterize the distribution of regional abnormalities in relation to findings on other cardiac imaging studies such as myocardial perfusion (MP) and magnetic resonance (MR) imaging.

Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).

Being tested
18F-mFBG for intravenous administration
Keywords
18F-mFBG, meta-fluorobenzylguanidine
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-mFBG for intravenous administrationDrug

    Also called meta-fluorobenzylguanidine, IRP101

    Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent

Study groups in NCT04535193
Study groupRoleWhat they receive
Low likelihood of coronary heart diseaseOtherThorax and total body imaging for quantification of normal biodistribution and myocardial sympathetic innervation. PET imaging to 210 minutes post-administration.
Receives: Drug: 18F-mFBG for intravenous administration
Heart Failure + left ventricular function (LVEF ≤ 35%)OtherThorax and total body imaging for quantification of myocardial sympathetic innervation. PET imaging to 100 minutes post-administration
Receives: Drug: 18F-mFBG for intravenous administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chang in 18F-mFBG uptake

    Change in 18F-mFBG uptake in the total body and the normal heart over time (based on serial PET images) to:

    • document the time course of global and regional myocardial activity reflecting specific uptake and clearance of the radiopharmaceutical;
    • estimate individual organ and whole-body radiation dosimetry.

    Measured: Up to 210 minutes after dosing

  2. Evaluation of 18F-mFBG for imaging myocardial sympathetic innervation

    To demonstrate the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of HF subjects with significant LV dysfunction (LVEF≤35%).

    Measured: Up to 100 minutes after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2020
  2. Study start5 Nov 2021
  3. Primary completion7 Mar 2025
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Model description
Study Cohort I will evaluate the myocardial update of 18F-mFBG (as a marker of sympathetic innervation) in control subject with a low likelihood of coronary heart disease. Study Cohort II will evaluate the myocardial update of 18F-mFBG (as a marker of sympathetic innervation) in stable patients with heart failure and reduced left ventricular function
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04535193
Sponsor's protocol ID
IRP101-121
Status last verified
Jun 2026
First submitted
26 Aug 2020
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 18F-mFBG for intravenous administration in people with Cardiovascular Diseases, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chang in 18F-mFBG uptake (time frame: Up to 210 minutes after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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