18F-mFBG Cardiac Uptake With Lewy Body Dementia

Part of paid clinical trials in Houston, Texas.

Sponsor
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Study ID
NCT07176286
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lewy Body Dementia (LBD)
  • Parkinson Disease (PD)

Eligibility Criteria

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

Interventions

  • 18F-MFBG — DRUG
    Intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG followed by whole body PET imaging.

Study Details

This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.

Key Dates

Start date
Apr 15, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Oct 30, 2026

Study Design

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

Arms

  • Active Comparator: Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)
    All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes.
  • Active Comparator: Cohort 2: neurologic disease due to non-Lewy body pathology.
    All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes.

Primary Outcome Measure

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)). [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Neurological InstituteHoustonTexas77030
Juan B Toledo, MD
[email protected]
713-441-1150

Find similar trials in Houston, TX

By research site
Houston Methodist Neurological Institute· Houston, TX

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