18F-mFBG Imaging for Myocardial Sympathetic Innervation
Sponsored by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
About this study
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to: * document the degree to which 18F-mFBG uptake in the heart is reduced (compared to historical controls) * characterize the distribution of regional abnormalities in relation to findings on rest/stress positron-emission tomography (PET) myocardial perfusion imaging (MPI) * determine if there are global and/or regional differences in myocardial sympathetic innervation between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months 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). Safety data will be collected to identify adverse events \[AEs\] and serious adverse events \[SAEs\] and characterize the safety profile of 18F-mFBG.
The focus of most research into myocardial sympathetic neuronal imaging has been on NE analogues labeled with gamma- or positron-emitting radioisotopes. The most widely studied conventional nuclear imaging agent is 123I-metaiodobenzylguanidine (123I-mIBG), which provides effective and well-validated semi-quantitative information. In the pivotal trial (ADMIRE-HF) on which the US approval of 123I-mIBG for cardiac imaging was based, there was an increased occurrence of adverse outcomes (composite of HF progression, potentially fatal arrhythmias, and cardiac death) in HF subjects based upon the heart/mediastinum (H/M) ratio on late ("delayed") planar 123I-mIBG (AdreView™) images. Analyses of all-cause mortality in the ADMIRE-HFX extension study confirmed the low risk associated with H/M ≥1.60 …
Where this study is enrolling
- I'm interested
UT Health Houston
Houston, Texas
Who can participate
Inclusion criteria
- ✓Stable heart failure from ischemic cardiomyopathy, LVEF \< or = 35%, ICD implantation for at least 12 months
Exclusion criteria
- ✕Unstable coronary artery disease, no ICD implantation
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Trial data sourced from ClinicalTrials.gov.