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18F-mFBG Imaging for Myocardial Sympathetic Innervation

NCT06965621 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

18F-metaFluorobenzylguanidine

PET Radiopharmaceutical to assess myocardial sympathetic innervation

DRUG

Rubidium-82

PET Radiopharmaceutical to assess myocardial perfusion

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

    lead INDUSTRY

Principal Investigators

  • K. Lance Gould, MD · Professor of Medicine, McGovern Medical School, UTHealth

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2026-10-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965621 on ClinicalTrials.gov