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18F-mFBG Cardiac Uptake for Lewy Body Dementia

This study is looking at how a special imaging agent called 18F-mFBG (a radioactive tracer) can help doctors see the effects of Parkinson's disease (PD) and Lewy body dementia (LBD) on your heart. You would receive an intravenous (IV) injection of 18F-mFBG, followed by a whole-body PET scan. The main goal is to measure how much 18F-mFBG your heart takes up, to understand the impact of these conditions on your heart's nerve signals. Researchers want to see if there's a measurable difference in heart uptake between people with Lewy body diseases and those without. This study is for adults aged 18 and older who are able to follow study procedures and give informed consent. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive an intravenous injection of 18F-mFBG followed by whole body PET imaging. The primary endpoint is measured at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months after the intervention to measure the primary endpoint.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07176286

18F-mFBG Cardiac Uptake With Lewy Body Dementia

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
~20 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:18F-MFBG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)).
Measured over 6 months

Conditions

Parkinson Disease (PD)
Lewy Body Dementia (LBD)

Explore related trials

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NCT07176286

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Houston Methodist Neurological Institute

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Juan B Toledo, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

Who to contact

Research Coordinator
[email protected]
346-238-2677
Email the study team

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Eligibility criteria

Inclusion

1\. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.

Exclusion

1\. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.

What this trial measures

  • Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)).6 months

    All image data will be analyzed to develop and validate quantitative measures of global and regional myocardial uptake of 18F-mFBG at two times between injection and 60 minutes post-administration. The data from subjects without Lewy body disease will be used in comparisons with equivalent results for Lewy body disease subjects. Results for subjects imaged in this study will also be compared with historical data from imaging of healthy control subjects without heart disease.