Parkinson DiseaseNUK-RBDNCT06629207
Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder
A study testing PET/CT with 18-FDG, SPECT : 123 I-FP-CIT (DATSCAN) and MRI in people with Parkinson Disease and REM Sleep Behavior Disorder, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, REM Sleep Behavior Disorder, Dementia, Lewy Body
- What is being tested?
- PET/CT with 18-FDG, SPECT : 123 I-FP-CIT (DATSCAN) and MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Oct 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders
- Written informed consent
Who cannot join
- Known diagnosis of PD or other neurodegenerative disorder
- Unequivocal signs of parkinsonism on examination
- Narcolepsy or other known causes of RBD
- Moderate to severe obstructive sleep apnea
- Abnormal neurological or MRI examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, University Clinic for Nuclear Medicine
Bern, 3010
Axel Rominger, Prof. Dr. med., +41 31 632 26 10, axel.rominger@insel.ch
Franziska Strunz, PhD, +41 31 66 4 30 22, studies.nuk@insel.ch
About this study
Official title: Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder
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.
- Being tested
- PET/CT with 18-FDG, SPECT : 123 I-FP-CIT (DATSCAN), MRI
- Keywords
- Parkinson Disease, Artificial Intelligence, REM Sleep Behavior Disorder
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT with 18-FDGDevice
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)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.
MRIDevice
MRI examination to exclude structural brain anomalies.
| Study group | Role | What they receive |
|---|---|---|
| NUK-RB Study | Experimental | Not described Receives: Device: PET/CT with 18-FDG; Device: SPECT : 123 I-FP-CIT (DATSCAN); Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Deep Learning Model Accuracy in Predicting Neurodegenerative Conversion in isolated REM sleep behavior disorder (iRBD) through Early Biomarker Detection
The investigators aim to evaluate the predictive accuracy of a deep learning model in identifying patients with iRBD who will progress to a neurodegenerative disorder. The primary outcome will assess the model's sensitivity in detecting early imaging biomarkers linked to disease progression, with the goal of enabling earlier intervention and improving long-term outcomes.
Measured: From enrollment to end of follow-up period, expected to be 48 months
Secondary outcomes (2)
Comparison of the Estimated versus Observed Annual Conversion Risk of Isolated Rapid Eye Movement Behavior Disorder (iRBD) to Neurodegenerative Disorders
The investigators aim to compare the estimated annual conversion risk of 6.3% in patients with iRBD to Parkinson's disease or another overt alpha-synucleinopathy with the conversion rates observed in the study.
Measured: From enrollment to end of follow-up period, expected to be 48 months
Evaluation of Deep Learning Model Accuracy in Predicting Conversion of Isolated REM Sleep Behavior Disorder (iRBD) to Parkinson's Disease
The investigators aim to evaluate the accuracy, receiver operating characteristic curves and area under the curve, specificity, and positive and negative predictive values of the applied deep learning method, predicting the conversion risk from iRBD to Parkinson's disease or another overt alpha-synucleinopathy.
Measured: From enrollment to end of follow-up period, expected to be 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start7 Oct 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuanggyu Shi, Prof. Dr. ing., Principal investigator, University Bern, Inselspital, Center for Artificial Intelligence in Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629207
- Sponsor's protocol ID
- 2023-00816
- Other IDs
- 2023
- Acronym
- NUK-RBD
- Status last verified
- Nov 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT06629207
- Acronym / sponsor ID
- NUK-RBD / 2023-00816
- Keywords
- Parkinson Disease, Artificial Intelligence, REM Sleep Behavior Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NUK-RB Study | Experimental | Device: PET/CT with 18-FDG, Device: SPECT : 123 I-FP-CIT (DATSCAN), Device: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders
- Written informed consent
Key exclusion criteria (5 listed)
- Known diagnosis of PD or other neurodegenerative disorder
- Unequivocal signs of parkinsonism on examination
- Narcolepsy or other known causes of RBD
- Moderate to severe obstructive sleep apnea
- Abnormal neurological or MRI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT with 18-FDGFDG-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. | Device | NUK-RB Study |
| 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. | Device | NUK-RB Study |
| MRIMRI examination to exclude structural brain anomalies. | Device | NUK-RB Study |
Primary outcome
Assessment of Deep Learning Model Accuracy in Predicting Neurodegenerative Conversion in isolated REM sleep behavior disorder (iRBD) through Early Biomarker Detection
Time frame: From enrollment to end of follow-up period, expected to be 48 months
The investigators aim to evaluate the predictive accuracy of a deep learning model in identifying patients with iRBD who will progress to a neurodegenerative disorder. The primary outcome will assess the model's sensitivity in detecting early imaging biomarkers linked to disease progression, with the goal of enabling earlier intervention and improving long-term outcomes.
2 secondary outcomes
Comparison of the Estimated versus Observed Annual Conversion Risk of Isolated Rapid Eye Movement Behavior Disorder (iRBD) to Neurodegenerative Disorders
Time frame: From enrollment to end of follow-up period, expected to be 48 months
Evaluation of Deep Learning Model Accuracy in Predicting Conversion of Isolated REM Sleep Behavior Disorder (iRBD) to Parkinson's Disease
Time frame: From enrollment to end of follow-up period, expected to be 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kuanggyu Shi, Prof. Dr. ing. principal investigator
University Bern, Inselspital, Center for Artificial Intelligence in Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT with 18-FDG, SPECT : 123 I-FP-CIT (DATSCAN) and MRI in people with Parkinson Disease and REM Sleep Behavior Disorder, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Axel Rominger, Prof. Dr. med. (+41 316322610, axel.rominger@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Deep Learning Model Accuracy in Predicting Neurodegenerative Conversion in isolated REM sleep behavior disorder (iRBD) through Early Biomarker Detection (time frame: From enrollment to end of follow-up period, expected to be 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.