An interventional study of PET/CT with 18-FDG and SPECT : 123 I-FP-CIT (DATSCAN) in Parkinson Disease, REM Sleep Behavior Disorder and Dementia, Lewy Body, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Diagnostic
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
Device: PET/CT with 18-FDG · Device: SPECT : 123 I-FP-CIT (DATSCAN) · Device: MRI
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.
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 examination to exclude structural brain anomalies.
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.
Time frame: From enrollment to end of follow-up period, expected to be 48 months
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.
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
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.
Time frame: From enrollment to end of follow-up period, expected to be 48 months
Plan to share: No
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Insel Gruppe AG, University Hospital Bern