Imaging with [18F]F-DOPA in patients with autonomic failure
Official title: [18F]F-DOPA Imaging in Patients With Autonomic Failure
Run by Vanderbilt University Medical Center · NCT04246437 · Data updated 2026-11-12
This study is testing a special imaging technique to see if it can help identify early signs of neurodegenerative diseases in people with autonomic failure.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | February 4, 2020 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2027 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT04246437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with pure autonomic failure or those with autonomic failure who may have Parkinson's disease, Multiple System Atrophy, or Dementia with Lewy Bodies.
✕Probably not a fit
Patients with bioimplants, ferromagnetic materials in their bodies, or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of [18F]F-DOPA imaging to assess biomarkers in patients with autonomic failure, particularly focusing on those who may develop neurodegenerative disorders such as Parkinson's disease, Multiple System Atrophy, or Dementia with Lewy Bodies. The study aims to identify the anatomical locations of alpha-synuclein inclusions and the patterns of neuronal death, which could help in predicting the progression of these conditions. Participants will receive [18F]FDOPA along with carbidopa and entacapone to facilitate imaging and analysis.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and treatment strategies for patients at risk of developing neurodegenerative diseases.
How similar studies have gone: While this approach is novel in the context of autonomic failure, similar imaging techniques have shown promise in other neurodegenerative disorders.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a diagnosis if pure autonomic failure 2. Patients with autonomic failure and possible PD, MSA, or DLB 3. Healthy adults aged 18 and above 4. Clinical exam confirming clinical designation Exclusion Criteria: * 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) Also excluded are subjects incapable of giving informed written consent: * 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
Where it's running
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Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Daniel O Claassen, MD, MS
- Email: daniel.claassen@vumc.org
- Phone: 615-936-1007
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.