NCT06965621 18F-mFBG Imaging for Myocardial Sympathetic Innervation
| NCT ID | NCT06965621 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-11-05 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
K. Lance Gould, MD
PRINCIPAL INVESTIGATOR
Professor of Medicine, McGovern Medical School, UTHealth
Frequently Asked Questions
Who can join the NCT06965621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06965621 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06965621 currently recruiting?
Yes, NCT06965621 is actively recruiting participants. Contact the research team at K.Lance.Gould@uth.tmc.edu for enrollment information.
Where is the NCT06965621 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06965621 clinical trial?
NCT06965621 is sponsored by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC). The principal investigator is K. Lance Gould, MD at Professor of Medicine, McGovern Medical School, UTHealth. The trial plans to enroll 20 participants.
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