18F-mFBG imaging to map heart nerve signals in people with ischemic heart failure and ICDs
Official title: 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
Run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · NCT06965621 · Data updated 2026-11-12
Researchers are testing whether 18F-mFBG PET imaging can see heart nerve activity in people with ischemic heart failure and an ICD.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | October 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT06965621 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Stable heart failure due to ischemic cardiomyopathy, LVEF ≤ 35%, and an ICD implanted for at least 12 months.
✕Probably not a fit
Patients without stable heart failure or those without an ICD, or those with unstable coronary disease, may not benefit from this imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2 trial evaluating 18F-mFBG as a PET imaging agent to quantify myocardial sympathetic innervation in stable ischemic cardiomyopathy patients with reduced ejection fraction and an ICD. The study aims to compare heart uptake to historical controls and to relate regional uptake patterns to rest and stress PET perfusion findings, as well as to prior ICD activations. Participants will undergo imaging with 18F-mFBG and Rubidium-82, with analysis focused on global and regional innervation differences and potential associations with arrhythmic risk. The trial builds on experience with 123I-mIBG but seeks quantitative advantages and standardization through PET. Safety, feasibility, and imaging performance will be assessed to inform future use in risk stratification and therapeutic planning.
Why it matters
Potential benefit: If successful, the imaging approach could improve risk stratification and guide management for patients with ischemic heart failure and ICDs by revealing nerve-related patterns in the heart.
How similar studies have gone: Prior work with 123I-mIBG has informed risk assessment, but PET-based 18F-mFBG offers potential advantages; this study explores feasibility and added value in a similar patient population.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
UT Health Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: K. Lance Gould, MD — Professor of Medicine, McGovern Medical School, UTHealth
- Study coordinator: K. Lance Gould, MD
- Email: K.Lance.Gould@uth.tmc.edu
- Phone: 713-704-2489
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.