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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
Sponsorprof. dr. Koen Van Laere

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

113 Participants
are divided into 4 treatment groups

Sponsors and collaborators

prof. dr. Koen Van Laere

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Sponsor institution

University Hospital, Ghent

Collaborator

Fund for Scientific Research, Flanders, Belgium

Collaborator

KU Leuven

Collaborator

Universitaire Ziekenhuizen KU Leuven

Collaborator