- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535193
Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation
An Open-Label, Exploratory, Phase 1/2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects Without and With Heart Disease
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: A F Jacobson, MD, PhD
- Phone Number: 401-375-2686
- Email: Jacobson@innervaterp.com
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- Recruiting
- Mount Sinai Morningside
-
Contact:
- Vikram Agarwal, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Low likelihood of coronary heart disease
Thorax and total body imaging for quantification of normal biodistribution and myocardial sympathetic innervation.
PET imaging to 210 minutes post-administration.
|
Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent
Other Names:
|
Other: Heart Failure + left ventricular function (LVEF ≤ 35%)
Thorax and total body imaging for quantification of myocardial sympathetic innervation.
PET imaging to 100 minutes post-administration
|
Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chang in 18F-mFBG uptake
Time Frame: Up to 210 minutes after dosing
|
Change in 18F-mFBG uptake in the total body and the normal heart over time (based on serial PET images) to:
|
Up to 210 minutes after dosing
|
Evaluation of 18F-mFBG for imaging myocardial sympathetic innervation
Time Frame: Up to 100 minutes after dosing
|
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%).
|
Up to 100 minutes after dosing
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vikram Agarwal, MD, Mount Sinai Morningside
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRP101-121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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