Actively Recruiting
[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD
Led by prof. dr. Koen Van Laere · Updated on 2025-02-06
113
Participants Needed
2
Research Sites
127 weeks
Total Duration
On this page
Sponsors
P
prof. dr. Koen Van Laere
Lead Sponsor
U
University Hospital, Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 85 years who provide written informed consent
- Use of effective birth control methods (for healthy controls)
- Good health based on medical history, physical exam, lab tests, and urinalysis
- No history or evidence of major neurological, internal, or psychiatric disorders (for healthy controls)
- Normal brain MRI scan for subjects under 60 years, or minor lesions allowed if 60 years or older (healthy controls)
- Adults aged 45 to 85 years with clinically established Parkinson's disease per Movement Disorder Society criteria
- Parkinson's disease patients with disease duration either less than 5 years or 5 years or longer
- Adults aged 45 to 85 years with clinically established or probable multiple system atrophy-parkinsonian variant
- Adults aged 50 to 85 years with probable Alzheimer's disease diagnosis showing evidence of disease process
- Adults aged 50 to 85 years with probable dementia with Lewy bodies diagnosis
- Ability to understand study information and provide written consent
You will not qualify if you...
- Major diseases or cognitive impairment interfering with healthy control participation
- History or evidence of psychiatric disease
- Use of illicit drugs or history of drug or alcohol abuse
- Chronic medication interfering with cardiac norepinephrine transporter or [18F]-FE-PE2I imaging
- Exposure to ionizing radiation over 1 mSv in other research within last 12 months
- Contraindications for MRI scanning
- Claustrophobia or inability to tolerate PET-MRI or PET scanning confinement
- Unwillingness to avoid strenuous physical activity
- Lack of understanding of study procedures
- Pregnancy or breastfeeding
- Lack of agreement to share incidental findings with general practitioner
- Abnormal Allen test or lidocaine allergy for those undergoing arterial sampling
- Neuropsychiatric diseases other than Parkinson's disease (for PD patients)
- Major internal medical diseases, especially diabetes or heart disease (for PD patients)
- Significant white matter lesions or other relevant MRI abnormalities
- History of alcohol or drug abuse
- Prior participation in studies involving ionizing radiation
- Anticoagulant therapy (for PD patients)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
UZ Ghent
Ghent, Gent, Belgium, 9000
Actively Recruiting
2
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
K
Koen Van Laere, Prof. dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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