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Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06965621

Phase 2 Study of 18F-mFBG PET Imaging for Heart Failure Patients with Ischemic Cardiomyopathy and Implantable Cardioverter-Defibrillators

Led by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Updated on 2026-07-01

20

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

I

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Lead Sponsor

U

University of Texas

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the radiopharmaceutical 18F-meta-fluorobenzylguanidine 18F-mFBG as a new imaging agent to measure myocardial sympathetic innervation in stable patients with heart failure due to ischemic cardiomyopathy. This Phase 2 study focuses on adults who have a left ventricular ejection fraction of 35% or less and have implantable cardioverter-defibrillators ICDs. The study aims to compare 18F-mFBG uptake with historical imaging agents and assess differences in sympathetic innervation related to past ICD activations. Participants will receive two PET radiopharmaceuticals intravenously 18F-mFBG to assess sympathetic innervation and Rubidium-82 to assess myocardial blood flow. The study groups consist of patients who have experienced ICD activation within the past 12 months and those who have not. Both imaging agents will be used to examine cardiac regions for abnormalities and to quantify myocardial uptake patterns during the study. During the trial, participants will undergo PET imaging and safety monitoring for 24 hours after the administration of these agents. Researchers will collect imaging data, evaluate heart function, and monitor for any adverse or serious adverse events. The study will assess how well 18F-mFBG works compared to previous imaging methods and gather safety information over the course of participation.

CONDITIONS

Brief Title

18F-mFBG Imaging for Myocardial Sympathetic Innervation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stable heart failure due to ischemic cardiomyopathy
  • Left ventricular ejection fraction (LVEF) 35% or less
  • Implantable cardioverter-defibrillator (ICD) implanted for at least 12 months
Not Eligible

You will not qualify if you...

  • Unstable coronary artery disease
  • No implantable cardioverter-defibrillator (ICD) implantation

Research Team

K

K. Lance Gould, MD

A

Amanda Roby

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