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[18F]F-DOPA Imaging in Autonomic Failure

This study is investigating how [18F]FDOPA (a special imaging agent) can help us understand conditions like Pure Autonomic Failure, Parkinson's Disease, Multiple System Atrophy, and Dementia with Lewy Bodies. You would receive an injection of [18F]FDOPA and have a 3-D emission scan (a type of imaging). Before the scan, you would also take oral doses of Carbidopa and Entacapone to improve the imaging results. Researchers will compare how [18F]FDOPA is taken up in the brain across different patient groups. The goal is to see if there are differences in [18F]FDOPA uptake that could help us better understand these conditions. The study plans to enroll 40 participants, including healthy adults and those with these conditions. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. It includes patients with autonomic failure conditions and healthy adults.
What's involved
You would receive an injection of [18F]FDOPA and take oral doses of Carbidopa and Entacapone. You would then undergo a 3-D emission scan lasting approximately 95 minutes.
Compensation
Not stated in the trial record.
Follow-up
Differences in FDOPA uptake will be measured at 95 minutes post-PET after the start of PET imaging.

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NCT04246437

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Recruiting
PHASE1Ages 18+InterventionalBasic science
Daniel Claassen
~40 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:[18F]FDOPACarbidopa 200mg oral doseEntacapone 400mg oral dose

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Differences in FDOPA uptake across patient populations
Measured over 95 minutes post-PET after start of PET imaging

Conditions

Autonomic Failure
Pure Autonomic Failure
Parkinson Disease
Multiple System Atrophy
Dementia With Lewy Bodies

Explore related trials

Lewy Body DementiaMultiple System AtrophyParkinson DiseasePure autonomic failure

Where it's being run

1 sites across 1 states
Tennessee1

Who to contact

Daniel O Claassen, MD, MS
[email protected]
615-936-1007
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.), because such devices may be displaced or malfunction.
Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
Subjects who have cerebral aneurysm clips.
Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
Subjects who are pregnant, because the effects of high field MRI on fetuses are not yet known.
Minors (younger than 18 years)
Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher.
Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders.
Prisoners

What this trial measures

  • Differences in FDOPA uptake across patient populations95 minutes post-PET after start of PET imaging

    Specific FDOPA uptake, Ki, will be calculated via a reference Logan plot to provide voxelwise measurements of FDOPA uptake. Mean uptake will be assessed in brain regions-of-interest in 40 participants to assess potential differences across different autonomic failure-related diseases.