Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder

NCT ID: NCT06629207

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2026-08-01

Brief Summary

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The study aims to systematically document the course of REM sleep behavior disorder (RBD) and investigate possible clinical and imaging biomarkers for disease progression and conversion risk to Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). The study will use artificial intelligence to analyze imaging and develop a reliable method to predict and stratify patients approaching conversion to overt a-synucleinopathy. Participants will be clinically evaluated and 2 imaging procedures will be done.

Detailed Description

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Conditions

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Parkinson Disease REM Sleep Behavior Disorder Dementia, Lewy Body

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NUK-RB Study

Group Type EXPERIMENTAL

PET/CT with 18-FDG

Intervention Type DEVICE

FDG-PET scans will be acquired in a Siemens Biograph Vision Quadra PET/CT (Siemens, Germany) at 30-minute post-injection of approximately 80 MBq 18F-FDG. The duration of the acquisition is 20 minutes. The PET images will be reconstructed with the vendor's time of flight (TOF) point-spread-function (PSF) algorithm, following corrections for randoms, scatter, and decay. Attenuation correction will be performed first using low-dose CT.

SPECT : 123 I-FP-CIT (DATSCAN)

Intervention Type DEVICE

DaT-Scans will be acquired in a GE Discovery NM/CT 670 Pro™. After injection of approximately 110 MBq 123I-FP-CIT, images will be acquired within 4 h post-injection. The duration of the acquisition is 35 minutes.

MRI

Intervention Type DEVICE

MRI examination to exclude structural brain anomalies.

Interventions

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PET/CT with 18-FDG

FDG-PET scans will be acquired in a Siemens Biograph Vision Quadra PET/CT (Siemens, Germany) at 30-minute post-injection of approximately 80 MBq 18F-FDG. The duration of the acquisition is 20 minutes. The PET images will be reconstructed with the vendor's time of flight (TOF) point-spread-function (PSF) algorithm, following corrections for randoms, scatter, and decay. Attenuation correction will be performed first using low-dose CT.

Intervention Type DEVICE

SPECT : 123 I-FP-CIT (DATSCAN)

DaT-Scans will be acquired in a GE Discovery NM/CT 670 Pro™. After injection of approximately 110 MBq 123I-FP-CIT, images will be acquired within 4 h post-injection. The duration of the acquisition is 35 minutes.

Intervention Type DEVICE

MRI

MRI examination to exclude structural brain anomalies.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders
2. Written informed consent

Exclusion Criteria

1. Known diagnosis of PD or other neurodegenerative disorder
2. Unequivocal signs of parkinsonism on examination
3. Narcolepsy or other known causes of RBD
4. Moderate to severe obstructive sleep apnea
5. Abnormal neurological or MRI examination
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuanggyu Shi, Prof. Dr. ing.

Role: PRINCIPAL_INVESTIGATOR

University Bern, Inselspital, Center for Artificial Intelligence in Medicine

Locations

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Inselspital, University Clinic for Nuclear Medicine

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Axel Rominger, Prof. Dr. med.

Role: CONTACT

+41 316322610

Franziska Strunz, PhD

Role: CONTACT

+41 316643022

Facility Contacts

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Axel Rominger, Prof. Dr. med.

Role: primary

+41 31 632 26 10

Franziska Strunz, PhD

Role: backup

+41 31 66 4 30 22

Other Identifiers

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2023-00816

Identifier Type: -

Identifier Source: org_study_id

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