18F-mFBG Imaging for Myocardial Sympathetic Innervation

Part of paid clinical trials in Houston, Texas.

Sponsor
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Study ID
NCT06965621
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 18F-metaFluorobenzylguanidine — DRUG
    PET Radiopharmaceutical to assess myocardial sympathetic innervation
  • Rubidium-82 — DRUG
    PET Radiopharmaceutical to assess myocardial perfusion

Study Details

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.

Key Dates

Start date
Apr 28, 2026
Status verified
Mar 2026
Primary completion
Oct 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Ischemic cardiomyopathy with ICD discharge
    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
  • Active Comparator: Ischemic cardiomyopathy without ICD discharge
    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

Primary Outcome Measure

Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease [ Time Frame: 24 hours from administration of the study drug for PET imaging and safety follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Health HoustonHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
UT Health Houston· Houston, TX

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