About this trial
Study goal:
The goal of this prospective head to head comparison is to evaluate the effectiveness of \[18F\]-MFBG PET in assessing cardiac innervation, comparing it with \[123I\]-MIBG SPECT The study's primary focus is on distinguishing between Parkinson's disease (PD) and multiple system atrophy (MSA), as well as between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD).
Main questions:
* Feasibility: How well can \[18F\]-MFBG PET detect changes in myocardial uptake in PD and DLB compared to the expected normal values in healthy individuals and AD and MSA-P patients? How well can it differentiate between these groups based on the detected changes? * Non-inferiority: Is \[18F\]-MFBG PET as accurate as \[123I\]-MIBG SPECT in distinguishing between PD and MSA-P, and between DLB and AD?
Participant requirements:
For the main study, participants will be required to visit the hospital for 3 or 4 appointments. During these visits, they will undergo a screening visit, MRI brain scan, a comprehensive neurological assessment, \[18F\]-PE2I PET, \[123I\]-MIBG SPECT, and \[18F\]-MFBG PET scans.
Additionally, a separate dosimetry study will be conducted, involving healthy subjects who will visit the hospital for a screening visit and undergo \[18F\]-MFBG PET scans.
Eligibility criteria
Qualifiers
Voluntary written informed consent.
Use of highly effective methods of birth control.
Age between 18 and 85 years.
Good health based on medical history, physical examination, clinical laboratory tests, and urinalysis.
Disqualifiers
Major diseases that may interfere with the investigations.
Evidence of cognitive impairment.
History or evidence of psychiatric disease.
Use of illicit drugs or history of drug or alcohol abuse.
Trial design
Treatments tested in this trial
- [18F]-MFBG PET CT
- [18F]-FE-PE2I PET CT or PET MRI
- [123I]-MIBG SPECT CT
- [18F]-MFBG PET dosimetry scans
Treatment groups
Sponsors and collaborators
prof. dr. Koen Van Laere
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Sponsor institution
University Hospital, Ghent
Collaborator
Fund for Scientific Research, Flanders, Belgium
Collaborator
KU Leuven
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator