18F-mFBG Imaging for Myocardial Sympathetic Innervation

Summary

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.

Timeline

Start

2025-11-05

Primary completion

2026-10-30

Completion

2026-12-30

Publications

• Background Nakajima K, Verschure DO, Okuda K, Verberne HJ. Standardization of 123I-meta-iodobenzylguanidine myocardial sympathetic activity imaging: phantom calibration and clinical applications. Clin Transl Imaging. 2017;5(3):255-263. doi: 10.1007/s40336-017-0230-2. Epub 2017 May 4.
• Background Verschure DO, Poel E, Travin MI, Henzlova MJ, Jain D, Jacobson AF, Verberne HJ. 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. Eur Heart J Cardiovasc Imaging. 2022 Aug 22;23(9):1201-1209. doi: 10.1093/ehjci/jeab132.
• Background Travin MI, Henzlova MJ, van Eck-Smit BLF, Jain D, Carrio I, Folks RD, Garcia EV, Jacobson AF, Verberne HJ. 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. J Nucl Cardiol. 2017 Apr;24(2):377-391. doi: 10.1007/s12350-015-0336-8. Epub 2016 Jan 20.
• Background Sood N, Al Badarin F, Parker M, Pullatt R, Jacobson AF, Bateman TM, Heller GV. 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. J Nucl Cardiol. 2013 Oct;20(5):813-20. doi: 10.1007/s12350-013-9750-y. Epub 2013 Jul 18.
• Background Narula J, Gerson M, Thomas GS, Cerqueira MD, Jacobson AF. (1)(2)(3)I-MIBG Imaging for Prediction of Mortality and Potentially Fatal Events in Heart Failure: The ADMIRE-HFX Study. J Nucl Med. 2015 Jul;56(7):1011-8. doi: 10.2967/jnumed.115.156406. Epub 2015 Jun 11.
• Background Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. 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. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. doi: 10.1016/j.jacc.2010.01.014. Epub 2010 Feb 25.

Drugs

Indications