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Comparison of Cardiac 18F-MFBG PET Versus 123I-MIBG SPECT to Differentiate Parkinsons Disease and Multiple System Atrophy, and Dementia with Lewy Bodies and Alzheimers Disease
Led by prof. dr. Koen Van Laere · Updated on 2025-02-06
113
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating the use of 18F-MFBG PET scans to assess heart nerve activity in people with Parkinsons disease PD, multiple system atrophy MSA, dementia with Lewy bodies DLB, and Alzheimers disease AD. The study compares this method with the current standard 123I-MIBG SPECT scans, focusing on distinguishing between PD and MSA as well as DLB and AD. This is a prospective study conducted at two centers, aiming to validate the accuracy and feasibility of 18F-MFBG PET for these neurological conditions. Participants will undergo several imaging tests including dynamic cardiac 18F-MFBG PET, 123I-MIBG SPECT, and cerebral 18F-PE2I PET scans. Healthy volunteers and patients with confirmed diagnoses will be included, with groups divided by age and disease duration. A dosimetry study will also be conducted for healthy volunteers to measure radiation exposure from 18F-MFBG. Multiple visits to the hospital are required for scans and assessments. During the study, participants will have thorough neurological assessments, brain MRI scans, and blood sampling alongside PET and SPECT imaging. Researchers will evaluate diagnostic accuracy, effect size of tracer uptake changes, and relationships between heart nerve imaging and brain dopamine transporter changes and autonomic dysfunction. The study includes monitoring for safety and will analyze regional heart uptake patterns. Participants can expect 3 to 4 hospital visits with detailed imaging and clinical evaluations over the study period.
CONDITIONS
Brief 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 volunteers aged 18 to 85 years in good health with no major neurological, internal, or psychiatric disorders
- Use of highly effective birth control methods for healthy volunteers
- Normal or minor MRI brain scan findings depending on age
- Adults aged 45 to 85 years with clinically established Parkinson's disease or multiple system atrophy with prior abnormal [18F]-FE-PE2I PET or [123I]-FP-CIT SPECT scan
- Adults aged 50 to 85 years with probable dementia due to Alzheimer's disease or dementia with Lewy bodies, with biomarker confirmation and prior abnormal brain scans where applicable
- Ability to understand study information and provide written informed consent
You will not qualify if you...
- Presence of major diseases or cognitive impairment in healthy controls
- History or evidence of psychiatric disease or substance abuse
- Use of chronic medication interfering with cardiac norepinephrine transporter or brain imaging
- Exposure to significant ionizing radiation in past 12 months
- Contraindications for MRI or PET scanning, including claustrophobia or inability to tolerate confinement
- Pregnancy or breastfeeding
- Lack of agreement to communicate incidental findings to general practitioner
- Presence of neuropsychiatric diseases other than Parkinson's disease in patient groups
- Major internal medical comorbidities such as diabetes or heart disease
- Significant white matter lesions or other relevant MRI abnormalities
- Anticoagulant therapy in patient groups
Research Team
K
Koen Van Laere, Prof. dr.
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