18F-mFBG Imaging for Myocardial Sympathetic Innervation
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · with University of Texas · NCT06965621
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
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