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Comparing scans of the nerves that supply the heart

Researchers compare imaging methods for assessing nerves supplying the heart, to help distinguish Parkinson’s and related brain conditions.

Testing a treatment or activity · Study reference: NCT06120049

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Start (reported actual date)
2024-01-19
Main measurements finished (planned)
2026-07
Study finished (planned)
2026-07

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

[18F]MFBG PET/CT imaging of myocardial sympathetic innervation in healthy controls and patients with parkinson's disease: dosimetry and pharmacokinetics.
Listed by the registry as research derived from the study · 2026

Who can join?

Ages 18 years to 85 years · Also accepts healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: 1. Healthy Controls: * 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. * No history or evidence of major neurological, internal, or psychiatric disorders. * Normal structural MRI scan for subjects \< 60 years or minor lesions for subjects \>= 60 years. 2. Parkinson's Disease: * Age 45-85 years. * Clinically established PD based on Movements Disorder Society diagnostic criteria. * Disease duration since onset of motor symptoms: 5 years or longer for one group and less than 5 years for another. * Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan. * Ability to understand the patient information brochure and provide written informed consent. 3. Multiple System Atrophy - Parkinsonian Variant: * Age 45-85 years. * Clinically established or clinically probable MSA-P based on MDS diagnostic criteria. * Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan. * Ability to understand the patient information brochure and provide written informed consent. 4. Dementia Due to Alzheimer's Disease: * Age 50-85 years. * Diagnosis of probable AD with evidence of the AD pathophysiological process. * Ability to understand the patient information brochure and provide written informed consent. 5. Dementia with Lewy Bodies: * Age 50-85 years. * Diagnosis of probable DLB. * Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan. * Ability to understand the patient information brochure and provide written informed consent. Exclusion Criteria: 1. Healthy controls: * 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. * Chronic medication interfering with cardiac neuronal norepinephrine transporter (NET) or \[18F\]-FE-PE2I imaging. * Exposure to ionizing radiation \> 1 mSv in other research studies within the last 12 months. * Contraindication for MRI scanning. * Claustrophobia or inability to tolerate confinement during PET-MRI scanning. * Unwillingness to avoid strenuous physical activity. * Lack of understanding of the study procedures. * Pregnancy or breastfeeding. * Lack of agreement to communicate incidental findings to the general practitioner. * Abnormal Allen test or lidocaine hypersensitivity/allergy for subjects willing to undergo arterial sampling. 2. Parkinson's Disease: * Neuropsychiatric diseases other than PD. * Major internal medical comorbidity, especially diabetes or heart disease. * White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities. * History of alcohol or drug abuse. * Previous participation in research studies involving ionizing radiation. * Contraindications for MR. * Claustrophobia or inability to tolerate confinement during PET scanning. * Unwillingness to avoid strenuous physical activity. * Lack of understanding of the study procedures. * Pregnancy or breastfeeding. * Lack of agreement to communicate incidental findings to the general practitioner. * Anticoagulant therapy. 3. Multiple System Atrophy - Parkinsonian Variant: * Same as for Parkinson's disease. 4. Dementia Due to Alzheimer's Disease: * Same as for Parkinson's disease. 5. Dementia with Lewy Bodies: * Same as for Parkinson's disease.
Full study name & original research details

Official study title

Prospective Head-to-head Comparison of Cardiac [18F]-MFBG PET Versus [123I]-MIBG SPECT in the Differentiation Between Parkinson's Disease and Multiple System Atrophy and Between Dementia With Lewy Bodies and Alzheimer's Disease

Short title used by the registry

[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD

Original description

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.

Further description from the registry

Study Rationale: This prospective study, to be conducted in two centers (UZ Leuven and UZ Gent), aims to validate cardiac \[18F\]-MFBG PET in distinguishing Parkinson's disease (PD) from multiple system atrophy (MSA-P) and differentiating dementia with Lewy bodies (DLB) from Alzheimer's disease (AD). Both PD and DLB, caused by alpha-synuclein deposits (Lewy bodies), exhibit not only nigrostriatal dopaminergic deficits but also early peripheral changes in myocardial norepinephrine (NE) innervation. These defects can be visualized and quantified using NE transporter tracers. \[18F\]-MFBG was developed several years ago with high-yield production and has already been employed in multiple centers worldwide, mainly in the context of imaging neuroendocrine tumors. \[18F\]-MFBG offers logistical, technical, and pharmacological advantages, including faster scanning, high spatial resolution, and improved quantification compared to the existing method using \[123I\]-MIBG SPECT. Participant Population: The study will include 28 healthy volunteers (CON), of which 3 will participate in \[18F\]-MFBG PET dosimetry (part 1) and 25 in the main study for optimization/age-dependence of cardiac \[18F\]-MFBG parameters (part 2). In part 3, 40 PD, 15 MSA-P, 15 DLB, and 15 AD patients with biomarker-confirmed diagnoses will be included. Total: 113 subjects. Intervention: All subjects will undergo three examinations in the main work packages (parts 2 and 3) dynamic cardiac \[18F\]-MFBG PET, with dynamic \[123I\]-MIBG SPECT as a comparator, as well as cerebral \[18F\]-PE2I PET. Endpoints: Primary: Non-inferiority in discriminating populations using \[18F\]-MFBG; Secondary: effect size, relationship between myocardial uptake and cerebral dopamine active transporter (DAT) changes, autonomic dysfunction, regional myocardial variation. Secondary: 1. Determine the effect size (ES) of the reduction in myocardial uptake of \[18F\]-MFBG in PD and DLB compared to \[123I\]-MIBG SPECT and \[123I\]-MIBG planar scintigraphy. 2. Identify any significant correlation between the reduction in myocardial uptake of \[18F\]-MFBG in PD and DLB and the reduction in \[18F\]-PE2I binding in early to moderate disease stages. 3. Assess the relationship between the reduction in myocardial uptake of \[18F\]-MFBG in PD and DLB and measures of autonomic dysfunction. 4. Examine the regional pattern of reduced \[18F\]-MFBG uptake in PD/DLB compared to controls, with an endpoint considered met if different regional segment scores are evident between PD/MSA-P or DLB/AD or subtypes of PD.

Conditions reported: Parkinson Disease; Dementia With Lewy Bodies; MSA - Multiple System Atrophy; Alzheimer Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
[18F]-MFBG PET CT; [18F]-FE-PE2I PET CT or PET MRI; [123I]-MIBG SPECT CT; [18F]-MFBG PET dosimetry scans
Phases
PHASE2; PHASE3
Sponsor
prof. dr. Koen Van Laere
Start date reported by registry
2024-01-19 (actual)

Registry updated: 2025-02-06 · Status last verified by the registry submitter: 2025-02

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Koen Van Laere, Prof. dr. · +3216343715 · koen.vanlaere@UZLeuven.be

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

UZ Ghent

Ghent, Gent, Belgium

Recruiting

Donatienne Van Weehaeghe, Dr. · +32 9 332 30 27 · donatienne.vanweehaeghe@uzgent.be

Donatienne Van Weehaeghe, Dr.

Patrick Santens, Prof. dr.

Tim Van Langenhove, Dr.

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Recruiting

Koen Van Laere, Prof. dr. · +3216343715 · koen.vanlaere@UZLeuven.be

Koen Van Laere, Prof. Dr.

Wim Vandenberghe, Prof. Dr.

Aline Delva, Dr.

Louis Versweyveld, Dr.

Facility not reported

Belgium

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.