Health TrialsbyHealthPanel

18F-mFBG Imaging for Myocardial Sympathetic Innervation

ConditionsHeart FailureIschemic CardiomyopathyICD Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unstable coronary artery disease, no ICD implantation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 18F-metaFluorobenzylguanidine

    Drug

    PET Radiopharmaceutical to assess myocardial sympathetic innervation

  • Rubidium-82

    Drug

    PET Radiopharmaceutical to assess myocardial perfusion

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Ischemic cardiomyopathy with ICD dischargeActive comparator 2 interventions
Group B: Ischemic cardiomyopathy without ICD dischargeActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease

Obtain computer quantification of global and/or regional differences in myocardial sympathetic innervation (based on 18F-mFBG uptake) between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months

Time frame
24 hours from administration of the study drug for PET imaging and safety follow-up

Secondary outcomes

1

Quanify regional patterns of 18F-mFBG myocardial uptake and distribution

Obtain comparative computer quantification of regional patterns of 18F-mFBG myocardial uptake (sympathetic innervation) and areas of abnormal myocardial perfusion (blood flow) and/or wall motion (myocardial contraction) on PET myocardial perfusion imaging with Rubidium-82.

Time frame
24 hours from administration of the study drug for PET imaging and safety follow-up
2

Perform Safety Data Collection for 18F-mFBG

Collect scheduled safety assessment data for 18F-mFBG Serious Adverse Events (SAE's) and Adverse Events (AE's).

Time frame
24 hours from administration of the study drug for safety follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Lead sponsor

University of Texas

Collaborator

Source ClinicalTrials.gov
Apply now