18F-mFBG Imaging for Myocardial Sympathetic Innervation

NCT06965621 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRP101-221
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Cardiomyopathy; ICD Patients; Heart Failure

Keywords

Myocardial sympathetic innervation; PET myocardial imaging; 18F-mFBG

Outcome Measures

Primary Outcomes (1)

• Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease

  Obtain computer quantification of global and/or regional differences in myocardial sympathetic innervation (based on 18F-mFBG uptake) between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months

  24 hours from administration of the study drug for PET imaging and safety follow-up

Secondary Outcomes (2)

• Quanify regional patterns of 18F-mFBG myocardial uptake and distribution

  24 hours from administration of the study drug for PET imaging and safety follow-up

• Perform Safety Data Collection for 18F-mFBG

  24 hours from administration of the study drug for safety follow-up

Study Arms (2)

Ischemic cardiomyopathy with ICD discharge

ACTIVE COMPARATOR

82Rb and 18F-mFBG will be administered to intraveously to 10 heart failure patients with ischemic cardiomyopathy and an ICD discharge within the past 12 months

Drug: 18F-metaFluorobenzylguanidine; Drug: Rubidium-82

Ischemic cardiomyopathy without ICD discharge

ACTIVE COMPARATOR

82Rb and 18F-mFBG will be administered intravenously to 10 heart failure patients with ischemic cardiomyopathy and no ICD discharge within the past 12 months

Drug: 18F-metaFluorobenzylguanidine; Drug: Rubidium-82

Interventions

Rubidium-82 DRUG

PET Radiopharmaceutical to assess myocardial perfusion

Ischemic cardiomyopathy with ICD discharge; Ischemic cardiomyopathy without ICD discharge

18F-metaFluorobenzylguanidine DRUG

PET Radiopharmaceutical to assess myocardial sympathetic innervation

Also known as: IRP101

Ischemic cardiomyopathy with ICD discharge; Ischemic cardiomyopathy without ICD discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable heart failure from ischemic cardiomyopathy, LVEF \< or = 35%, ICD implantation for at least 12 months

You may not qualify if:

• Unstable coronary artery disease, no ICD implantation

Sponsors & Collaborators

• University of Texas: collaborator
• Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC): lead

Study Sites (1)

UT Health Houston

Houston, Texas, 77030, United States

Location

Related Publications (6)

• 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.

  PMID: 28596948 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.

  PMID: 34427293 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.

  PMID: 26791866 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.

  PMID: 23864400 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.

  PMID: 26069309 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.

  PMID: 20188504 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Rubidium-82

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• K. Lance Gould, MD

  Professor of Medicine, McGovern Medical School, UTHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

K. Lance Gould, MD

CONTACT

713-704-2489; K.Lance.Gould@uth.tmc.edu

Amanda Roby

CONTACT

713-704-2489; Amanda.E.Roby@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: May 11, 2025
• Study Start: April 28, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)