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Status:

RECRUITING

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

Lead Sponsor:

prof. dr. Koen Van Laere

Collaborating Sponsors:

University Hospital, Ghent

Fund for Scientific Research, Flanders, Belgium

Conditions:

Parkinson Disease

Dementia With Lewy Bodies

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

PHASE3

Brief Summary

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...

Detailed Description

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 sys...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 19 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

113 Patients enrolled

Trial Details

Trial ID

NCT06120049

Start Date

January 19 2024

End Date

July 1 2026

Last Update

February 6 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

UZ Ghent

Ghent, Gent, Belgium, 9000

2

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000