Actively Recruiting
[18F]F-DOPA Imaging in Patients With Autonomic Failure
Led by Daniel Claassen · Updated on 2026-03-16
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Alpha-synucleinopathies are age-related neurodegenerative disorders characterized by the build-up of alpha-synuclein in nerve cells, leading to conditions like Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies. Pure Autonomic Failure is a related condition affecting the peripheral autonomic nervous system and may signal risk for developing central nervous system synucleinopathies. Researchers aim to identify biomarkers, especially changes in dopamine production in key brain areas, to predict progression from peripheral to central disease. Participants receive a radiolabeled drug called [18F]F-DOPA, which is used in PET scans to study dopamine activity in the brain. Before the PET scan, patients take oral doses of carbidopa and entacapone to enhance imaging quality by reducing peripheral metabolism of [18F]F-DOPA. The PET scan involves a slow injection of [18F]F-DOPA followed by about 95 minutes of serial brain imaging to observe dopamine-related changes. During the study, participants undergo clinical exams to confirm diagnosis and receive the PET imaging procedure. Researchers measure differences in [18F]F-DOPA uptake across patient groups 95 minutes after imaging starts to assess dopamine function. The study includes patients with autonomic failure, possible synucleinopathies, and healthy adults aged 18 and older. The study is designed to monitor safety and gather detailed imaging data over the scan period.
CONDITIONS
Brief Title
[18F]F-DOPA Imaging in Patients With Autonomic Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with pure autonomic failure
- Patients with autonomic failure and possible Parkinson's disease, multiple system atrophy, or dementia with Lewy bodies
- Healthy adults aged 18 years and older
- Clinical exam confirming diagnosis
You will not qualify if you...
- Presence of bioimplants activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, infusion pumps)
- Presence of any ferromagnetic bioimplants that could be displaced
- Presence of cerebral aneurysm clips
- Embedded shrapnel or metallic fragments in or near the eyes
- Pregnancy
- Age under 18 years
- Inability to give informed written consent
- Limited mental ability or psychiatric disorders affecting consent
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 to 3 hours on the treatment day
Participants receive oral doses of carbidopa and entacapone 30 minutes prior to a PET scan with a 3-D emission scan following a slow bolus injection of [18F]FDOPA to measure pre-synaptic dopamine in the brain.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
D
Daniel O Claassen, MD, MS
K
Kaitlyn O'Rourke, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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