18F-mFBG Imaging for Heart Failure

Overseen By Amanda Roby

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Disqualifiers: Unstable coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

K. Lance Gould, MD

Principal Investigator

Professor of Medicine, McGovern Medical School, UTHealth

Eligibility Criteria

This trial is for stable heart failure patients with ischemic cardiomyopathy, who have a left ventricular ejection fraction (LVEF) of 35% or less and have had an implantable cardioverter-defibrillator (ICD) for at least a year. It's not open to those without ICDs or with unstable coronary artery disease.

Inclusion Criteria

I have stable heart failure with a low heart pump function and have had an ICD for over a year.

Exclusion Criteria

No ICD implantation

I have unstable heart artery disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Administration of 82Rb and 18F-mFBG intravenously to heart failure patients for PET imaging

1 day

1 visit (in-person)

Safety Follow-up

Safety data collection for 18F-mFBG, including adverse events and serious adverse events

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 18F-metaFluorobenzylguanidine

Trial Overview The study tests the imaging agent 18F-mFBG in comparison to historical controls using other agents like mIBG and HED. It aims to measure myocardial sympathetic innervation in heart failure patients through PET scans, assessing uptake levels and regional abnormalities.

Participant Groups

Group I: Ischemic cardiomyopathy with ICD discharge Active Control 2 Interventions

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

Group II: Ischemic cardiomyopathy without ICD discharge Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Lead Sponsor

Trials

3

Recruited

60+

University of Texas

Collaborator

Trials

193

Recruited

143,000+