Phase 2 Study of 18F-mFBG PET Imaging
for Heart Failure Patients with Ischemic Cardiomyopathy
and Implantable Cardioverter-Defibrillators
Led by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Updated on 2026-07-01
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the radiopharmaceutical 18F-meta-fluorobenzylguanidine 18F-mFBG as a new imaging agent to measure myocardial sympathetic innervation in stable patients with heart failure due to ischemic cardiomyopathy. This Phase 2 study focuses on adults who have a left ventricular ejection fraction of 35% or less and have implantable cardioverter-defibrillators ICDs. The study aims to compare 18F-mFBG uptake with historical imaging agents and assess differences in sympathetic innervation related to past ICD activations.
Participants will receive two PET radiopharmaceuticals intravenously 18F-mFBG to assess sympathetic innervation and Rubidium-82 to assess myocardial blood flow. The study groups consist of patients who have experienced ICD activation within the past 12 months and those who have not. Both imaging agents will be used to examine cardiac regions for abnormalities and to quantify myocardial uptake patterns during the study.
During the trial, participants will undergo PET imaging and safety monitoring for 24 hours after the administration of these agents. Researchers will collect imaging data, evaluate heart function, and monitor for any adverse or serious adverse events. The study will assess how well 18F-mFBG works compared to previous imaging methods and gather safety information over the course of participation.
CONDITIONS
Brief Title
18F-mFBG Imaging for Myocardial Sympathetic Innervation
Research Team
K
K. Lance Gould, MD
A
Amanda Roby
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
18F-mFBG PET Imaging
Current Cardiac Sympathetic Innervation Imaging
What it is
A PET imaging radiotracer, 18F-metaFluorobenzylguanidine (18F-mFBG), is used to visualize and quantify cardiac sympathetic nerve activity in adults with heart failure due to ischemic cardiomyopathy.
The current established method, 123I-meta-iodobenzylguanidine (123I-MIBG) SPECT or PET, is used to assess cardiac sympathetic innervation in patients with heart failure for diagnostic and risk evaluation purposes.
Role in trial
Evaluated as an investigational imaging agent to identify and quantify abnormalities in cardiac sympathetic innervation among patients with ischemic cardiomyopathy and heart failure.
Serves as the established reference for assessing myocardial sympathetic activity in heart failure, used for diagnosis, risk stratification, and therapy decision support.
Primary use
To noninvasively visualize cardiac nerve activity in patients with a history of heart failure due to ischemic cardiomyopathy and an implanted ICD.
Used to assess sympathetic nervous system dysfunction in heart failure, aiding in diagnosis and predicting arrhythmic risk.
How it is performed
Participants receive an intravenous injection of 18F-mFBG followed by PET imaging to assess myocardial uptake and distribution.
Patients receive an injection of 123I-MIBG, and SPECT or PET scans are performed after a standardized waiting period to measure cardiac tracer uptake.
Evidence status
No results are posted for this investigational PET approach; evidence from published use in heart failure populations is not yet established.
123I-MIBG imaging is supported by published studies demonstrating utility for risk stratification and outcome prediction in patients with heart failure.
Important limitations
Not yet established in routine care; clinical experience and safety profile in this population remain under investigation.
Availability varies by region and center; success depends on technical quality, standardized protocols, and interpretation experience.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Stable heart failure due to ischemic cardiomyopathy
Left ventricular ejection fraction (LVEF) 35% or less
Implantable cardioverter-defibrillator (ICD) implanted for at least 12 months
You will not qualify if you...
Unstable coronary artery disease
No implantable cardioverter-defibrillator (ICD) implantation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Imaging and Safety Monitoring
Duration - 24 hours
Participants receive two PET imaging agents intravenously to assess heart nerve function and blood flow. Imaging scans and safety monitoring occur for 24 hours after administration.
1 visit with imaging and follow-up
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Resting perfusion MPI-SPECT combined with cardiac 123I-mIBG sympathetic innervation imaging improves prediction of arrhythmic events in non-ischemic cardiomyopathy patients: sub-study from the ADMIRE-HF trial.
Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study.
Arnold F Jacobson, Roxy Senior, Manuel D Cerqueira...
A simplified wall-based model for regional innervation/perfusion mismatch assessed by cardiac 123I-mIBG and rest 99mTc-tetrofosmin SPECT to predict arrhythmic events in ischaemic heart failure.
Assessment of 123I-mIBG and 99mTc-tetrofosmin single-photon emission computed tomographic images for the prediction of arrhythmic events in patients with ischemic heart failure: Intermediate severity innervation defects are associated with higher arrhythmic risk.
Mark I Travin, Milena J Henzlova, Berthe L F van Eck-Smit...