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An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With Heart Failure and Implantable Cardioverter-Defibrillators

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
United States
Texas
UT Health Houston
RECRUITING
Houston
Contact Information
Primary
K. Lance Gould, MD
K.Lance.Gould@uth.tmc.edu
713-704-2489
Backup
Amanda Roby
Amanda.E.Roby@uth.tmc.edu
713-704-2489
Time Frame
Start Date: 2025-11-05
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 20
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Collaborators: University of Texas

This content was sourced from clinicaltrials.gov