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RecruitingPhase 2

18F-mFBG Imaging for Myocardial Sympathetic Innervation

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · with University of Texas · NCT06965621

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
20
US sites recruiting
1
Study start
November 5, 2025
Record last updated
July 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: 18F-metaFluorobenzylguanidine; Rubidium-82

Conditions: Heart Failure; Ischemic Cardiomyopathy; ICD Patients

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • UT Health Houston

    Houston, TX 77030

    Site contact: K. Lance Gould, MD Principal Investigator · 713-704-2474 · k.lance.gould@uth.tmc.edu

Study contacts (from the official record)

  • K. Lance Gould, MD · 713-704-2489 · K.Lance.Gould@uth.tmc.edu
  • Amanda Roby · 713-704-2489 · Amanda.E.Roby@uth.tmc.edu
18F-mFBG Imaging for Myocardial Sympathetic Innervation (NCT06965621) | Bored Studies