Imaging with [18F]F-DOPA in patients with autonomic failure
[18F]F-DOPA Imaging in Patients With Autonomic Failure
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 |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04246437 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with bioimplants, ferromagnetic materials in their bodies, or those who are pregnant will not benefit from this study.
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 performed: While this approach is novel in the context of autonomic failure, similar imaging techniques have shown promise in other neurodegenerative disorders.
Eligibility criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.