RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Alpha-synucleinopathies refer to age-related neurodegenerative and dementing disorders, characterized by the accumulation of alpha-synuclein in neurons and/or glia. The anatomical location of alpha-synuclein inclusions (Lewy Bodies) and the pattern of progressive neuronal death (e.g. caudal to rostral brainstem) give rise to distinct neurological phenotypes, including Parkinson's disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB). Common to these disorders are the involvement of the central and peripheral autonomic nervous system, where Pure Autonomic Failure (PAF) is thought (a) to be restricted to the peripheral autonomic system, and (b) a clinical risk factor for the development of a central synucleinopathy, and (c) an ideal model to assess biomarkers that predict phenoconversion to PD, MSA, or DLB. Such biomarkers would aid in clinical trial inclusion criteria to ensure assessments of disease- modifying strategies to, delay, or halt, the neurodegenerative process. One of these biomarkers may be related to the neurotransmitter dopamine (DA) and related changes in the substantia nigra (SN) and brainstem. \[18F\]F-DOPA is a radiolabeled substrate for aromatic amino acid decarboxylase (AAADC), an enzyme involved in the production of dopamine. Use of this radiolabeled substrate in positron emission tomography (PET) may provide insight to changes in monoamine production and how they relate to specific phenoconversions in PAF patients. Overall, this study aims to identify changes in dopamine production in key regions including the SN, locus coeruleus, and brainstem to distinguish between patients with PD, MSA, and DLB, which may provide vital information to predict conversion from peripheral to central nervous system disease.

Official Title

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

Quick Facts

Study Start:2020-02-04
Study Completion:2025-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04246437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with a diagnosis if pure autonomic failure
  2. 2. Patients with autonomic failure and possible PD, MSA, or DLB
  3. 3. Healthy adults aged 18 and above
  4. 4. Clinical exam confirming clinical designation
  1. * 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.
  2. * Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
  3. * Subjects who have cerebral aneurysm clips.
  4. * 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).
  5. * Subjects who are pregnant, because the effects of high field MRI on fetuses are not yet known.
  6. * Minors (younger than 18 years)
  7. * Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher.
  8. * Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders.
  9. * Prisoners

Contacts and Locations

Study Contact

Daniel O Claassen, MD, MS
CONTACT
615-936-1007
daniel.claassen@vumc.org
Kaitlyn Hay, MS
CONTACT
kaitlyn.r.hay@vumc.org

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Daniel Claassen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-04
Study Completion Date2025-02-01

Study Record Updates

Study Start Date2020-02-04
Study Completion Date2025-02-01

Terms related to this study

Keywords Provided by Researchers

  • FDOPA
  • PET

Additional Relevant MeSH Terms

  • Autonomic Failure
  • Pure Autonomic Failure
  • Parkinson Disease
  • Multiple System Atrophy
  • Dementia with Lewy Bodies