UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062990 |
|---|---|
| Receipt number | R000072102 |
| Scientific Title | Exploratory Collaborative Observational Study of the Association Between Imaging Features Derived from Brain MRI and Nuclear Medicine Imaging Indices in Parkinsonian Syndromes |
| Date of disclosure of the study information | 2026/09/26 |
| Last modified on | 2026/09/19 08:39:56 |
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Basic information
Public title
A Study of the Relationship Between Brain MRI Findings and Nuclear Medicine Test Results in Parkinsonian Syndromes
Acronym
MRI and Nuclear Medicine Imaging in Parkinsonian Syndromes Study
Scientific Title
Exploratory Collaborative Observational Study of the Association Between Imaging Features Derived from Brain MRI and Nuclear Medicine Imaging Indices in Parkinsonian Syndromes
Scientific Title:Acronym
PS-MRI/NM Study
Region
| Japan |
Condition
Condition
Parkinsonian Syndrome
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between imaging information derived from brain MRI and nuclear medicine imaging indices associated with parkinsonian syndromes, and to explore the potential of novel MRI-based imaging analysis methods.
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between brain MRI findings and nuclear medicine imaging indices.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The error and agreement between MRI-derived estimated indices and measured indices obtained from nuclear medicine imaging.
Key secondary outcomes
1. Performance of brain MRI-based analysis for classifying nuclear medicine imaging findings as normal or abnormal.
2. Performance of the imaging analysis method taking into account prediction uncertainty and indeterminate cases.
3. Evaluation of the potential clinical utility of brain MRI-based imaging analysis.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Parkinson disease (PD), dementia with Lewy bodies (DLB), essential tremor (ET), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), or isolated REM sleep behavior disorder (iRBD), as well as individuals who were initially suspected of having parkinsonian syndrome (PS), including PD, but had a normal DaTscan result, will be eligible if they attended the Department of Neurology, Juntendo University Hospital, between January 1, 2010 and the date of study approval and underwent both brain MRI and DaTscan examinations.
Inclusion Criteria
1. DaTscan must have been performed within 12 months before or after the brain MRI examination.
2. Participants must have a clinical diagnosis of PD, DLB, ET, PSP, MSA, or iRBD, or must have been initially suspected of having PS, including PD, but subsequently had a normal DaTscan result.
Reference Diagnostic Criteria
PD: Clinically established PD or clinically probable PD according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson Disease.
DLB: Probable or possible DLB according to the Fourth Consensus Report of the DLB Consortium (McKeith et al., 2017).
PSP: Probable or possible PSP according to the 2017 MDS Diagnostic Criteria for PSP.
MSA: Clinically established MSA or clinically probable MSA according to the 2022 MDS Diagnostic Criteria for MSA.
iRBD: REM sleep behavior disorder meeting the 2023 AASM ICSD-3-TR diagnostic criteria for RBD, without secondary causes or manifest neurological disease.
The group with normal DaTscan results may include healthy individuals and patients with drug-induced parkinsonism (DIP), vascular parkinsonism (VaP), idiopathic normal pressure hydrocephalus (iNPH), and other conditions.
Key exclusion criteria
Exclusion Criteria
1. Patients with a history of head trauma, metabolic disease, severe psychiatric illness, or other central nervous system disorders.
2. Patients taking any of the following medications: sertraline, reserpine, amphetamines, methamphetamine, cocaine, methylphenidate, bupropion, mazindol, phentermine, benztropine, modafinil, or tetrabenazine.
3. Patients who are deemed inappropriate for participation in the study by the principal investigator.
Target sample size
1940
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Sako |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
w.sako.fn@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Sako |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
w.sako.fn@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Wataru Sako
Funding Source
Organization
MEDICOLAB, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Clinical Research and Trial center
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
03-3814-5672
research-funds@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E26-0087
Org. issuing International ID_1
Juntendo Clinical Research and Trial center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study.
Management information
Registered date
| 2026 | Year | 09 | Month | 19 | Day |
Last modified on
| 2026 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072102
