ClinicalTrials.gov record NCT06120049

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2/3A study that tests whether a treatment works while continuing to check safety, in a larger group than a phase 2 study alone. It combines the aims of phase 2 and phase 3 in one protocol.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 85 years old
SexAll
LocationBelgium
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective head-to-head study compares cardiac [18F]-MFBG PET with [123I]-MIBG SPECT, plus [18F]-FE-PE2I brain PET, to evaluate imaging of heart nerve (myocardial) uptake. It includes people with Parkinson disease, MSA‑P, dementia with Lewy bodies, Alzheimer's disease, and healthy volunteers. Participants attend multiple hospital visits for MRI, clinical assessment, and several PET/SPECT scans; a small healthy dosimetry group has extended whole-body scanning.

What it is studying. The study tests whether cardiac [18F]-MFBG PET can detect reduced myocardial norepinephrine innervation and whether it is non-inferior to [123I]-MIBG SPECT for distinguishing PD versus MSA‑P and DLB versus AD. It also examines links between myocardial uptake, brain dopamine transporter imaging ([18F]-FE-PE2I), and measures of autonomic dysfunction, and includes dosimetry in healthy volunteers.

What the researchers hope to learn. Validate cardiac [18F]-MFBG PET to distinguish Parkinson disease from MSA‑P and dementia with Lewy bodies from Alzheimer's disease; test non-inferiority versus [123I]-MIBG SPECT; quantify effect sizes of myocardial tracer uptake differences; assess relationships between myocardial uptake and brain dopamine transporter imaging and autonomic dysfunction; map regional myocardial uptake patterns; obtain dosimetry data in healthy volunteers.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • [18F]-MFBG PET CT
  • [18F]-FE-PE2I PET CT or PET MRI
  • [123I]-MIBG SPECT CT
  • [18F]-MFBG PET dosimetry scans

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.
  • 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.
  • 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.
  • 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.
  • 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

  • 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.
  • 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.
  • Multiple System Atrophy - Parkinsonian Variant:
  • Same as for Parkinson's disease.
  • Dementia Due to Alzheimer's Disease:
  • Same as for Parkinson's disease.
  • Dementia with Lewy Bodies:
  • Same as for Parkinson's disease.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed 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:

  • 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.
  • 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.
  • Assess the relationship between the reduction in myocardial uptake of [18F]-MFBG in PD and DLB and measures of autonomic dysfunction.
  • 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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will make about 3–4 hospital visits for screening, a brain MRI and neurological assessment, a brain 18F‑FE‑PE2I PET, a 123I‑MIBG SPECT heart scan, and dynamic cardiac 18F‑MFBG PET scans (early and late timepoints). Venous blood samples are taken during the 18F‑MFBG PET; a small number of healthy volunteers may have arterial blood sampling and multiple whole‑body PET scans with urine collection for dosimetry. Some scans may include a short whole‑body PET/CT; participants must be able to tolerate PET/MR or PET/CT confinement and avoid strenuous activity as requested.

How the study is structured. Interventional diagnostic imaging study that assigns participants to imaging tests (no masking). Non-randomized, parallel groups comparing cohorts (healthy controls, PD, MSA‑P, DLB, AD). Participants undergo dynamic cardiac [18F]-MFBG PET, [123I]-MIBG SPECT, and [18F]-FE-PE2I brain PET plus MRI and clinical assessments across several visits; a small subgroup has extended whole-body dosimetry scans.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Belgium. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 19, 2024
Primary completion
July 2026 (estimated)
Study completion
July 2026 (estimated)
Target enrollment
113 participants (estimated)
Last updated on registry
Feb 6, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
prof. dr. Koen Van Laere
Collaborators
  • University Hospital, Ghent
  • Fund for Scientific Research, Flanders, Belgium
  • KU Leuven
  • Universitaire Ziekenhuizen KU Leuven

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

  • UZ GhentRecruiting

    Ghent, Gent, 9000 · Belgium

  • UZ LeuvenRecruiting

    Leuven, Vlaams-Brabant, 3000 · Belgium

Terms used on this page · explanations by MedicalUpdates.ai

PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
Non-inferiority
What a comparison is designed to show. A superiority study asks whether the new treatment is better than the comparator; a non-inferiority study asks whether it is not meaningfully worse.
screening visit
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
comparator
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
Endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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