[18F]MFBG PET/CT imaging of myocardial sympathetic innervation in healthy controls and patients with parkinson's disease: dosimetry and pharmacokinetics.
Louis Versweyveld, Aline Delva, Marie Cohilis...
https://pubmed.ncbi.nlm.nih.gov/40924149Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID06120049
Comparison of Cardiac [18F]-MFBG PET Versus [123I]-MIBG SPECT to Differentiate Parkinson's Disease and Multiple System Atrophy, and Dementia with Lewy Bodies and Alzheimer's 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 Parkinson's disease (PD), multiple system atrophy (MSA), dementia with Lewy bodies (DLB), and Alzheimer's 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
Age: 18Years - 85Years
All Genders
Healthy Volunteers
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single-day or multiple days depending on scheduling
Participants undergo three diagnostic imaging examinations: cardiac [18F]-MFBG PET, [123I]-MIBG SPECT, and cerebral [18F]-PE2I PET to differentiate Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and Alzheimer's disease.
3 visits (in-person) for imaging scans
Dosimetry Scans
Duration - Approximately 6 hours on scan day
A small group of healthy volunteers undergo extended [18F]-MFBG PET dosimetry scans involving multiple whole-body scans to assess tracer distribution and safety.
1 visit (in-person) with multiple scan segments and urine collection
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
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Research Team
K
Koen Van Laere, Prof. dr.
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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