Recruiting
Phase 2

18F-mFBG

Sponsor:

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Code:

NCT06965621

Conditions

Heart Failure

Ischemic Cardiomyopathy

ICD Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-metaFluorobenzylguanidine

Rubidium-82

Study Details

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

Heart Failure

Ischemic Cardiomyopathy

ICD Patients

Study ID

NCT06965621

Start date

Nov 5, 2025

Status verified date

Jun, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Ischemic cardiomyopathy with ICD discharge

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

active comparator: Ischemic cardiomyopathy without ICD discharge

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

Interventions

18F-metaFluorobenzylguanidine

PET Radiopharmaceutical to assess myocardial sympathetic innervation

Rubidium-82

PET Radiopharmaceutical to assess myocardial perfusion

Primary outcome measure

  • Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease [ Time Frame: 24 hours from administration of the study drug for PET imaging and safety follow-up ]

Central Contacts and Locations

Central contacts

K. Lance Gould, MD

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

Amanda Roby

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

Locations

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

K. Lance Gould, MD Principal Investigator

713-704-2474k.lance.gould@uth.tmc.edu

Patricia Study Coordinator

713-704-2474Patricia.M.Mendoza@uth.tmc.edu

Principal Investigator:

K. Lance Gould, MD

More Information

Sponsor

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) on 2026-07-01.