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18F-mFBG Imaging for Myocardial Sympathetic Innervation

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Apr 28, 2026 to Nov 5, 2025 · Site details revisedv6 Show 2 more changesShow less
    • Start date changed from estimate of Apr 28, 2026 to Nov 5, 2025
    • Site details revised
  2. Start date: Nov 30, 2025 to Apr 28, 2026 Primary completion date: May 30, 2026 to Oct 30, 2026 · Completion date: Jul 30, 2026 to Dec 30, 2026v5 Show 2 more changesShow less
    • Primary completion date: May 30, 2026 to Oct 30, 2026
    • Completion date: Jul 30, 2026 to Dec 30, 2026
  3. Start date: Sep 30, 2025 to Nov 30, 2025 Primary completion date: Mar 30, 2026 to May 30, 2026 · Completion date: Jun 30, 2026 to Jul 30, 2026v4 Show 2 more changesShow less
    • Primary completion date: Mar 30, 2026 to May 30, 2026
    • Completion date: Jun 30, 2026 to Jul 30, 2026
  4. Start date: Aug 1, 2025 to Sep 30, 2025 Primary completion date: May 1, 2026 to Mar 30, 2026 · Completion date: Jun 1, 2026 to Jun 30, 2026v3 Show 2 more changesShow less
    • Primary completion date: May 1, 2026 to Mar 30, 2026
    • Completion date: Jun 1, 2026 to Jun 30, 2026
  5. Start date: Jun 1, 2025 to Aug 1, 2025v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06965621
Lead Sponsor Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Collaborators: University of Texas
Conditions Heart Failure, Ischemic Cardiomyopathy, ICD Patients
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov