UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014389 |
|---|---|
| Receipt number | R000016710 |
| Scientific Title | Pathophysiological analysis of Parkinson disease and related disorders using DAT scan and MRI |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2019/12/30 10:46:59 |
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Basic information
Public title
Pathophysiological analysis of Parkinson disease and related disorders using DAT scan and MRI
Acronym
Morphological and functional imaging assessment of Parkinson disease
Scientific Title
Pathophysiological analysis of Parkinson disease and related disorders using DAT scan and MRI
Scientific Title:Acronym
Morphological and functional imaging assessment of Parkinson disease
Region
| Japan |
Condition
Condition
Parkinson disease and related disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this work is to solve the pathophysiology of a Parkinson disease and related disorders by using multimodal neuroimaging including DAT scan and magnetic resonance imaging.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
activity of striatal dopamine transporters in Parkinson disease
Key secondary outcomes
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy control
Patients with Parkinson disease and related disorders
Key exclusion criteria
1. Patients who are severe hepatic dysfunction
2. Patients who are severe renal dysfunction or dialysis ESRD
3. Patients who are past history of hypersensitivity to Alcohol
4. Patients who are taking medicine which affects the uptake of [123I]-Ioflupane
5. Patients who have voiding dysfunction
6. Pregnant or woman of child-bearing potential
7. The woman under breast-feeding
8. Patients who were implanted metallic or electrical devices
9. Patients who are judged as inappropriate for inclusion by physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kamagata |
Organization
Juntendo University Graduated School of Medicine
Division name
Department of Radiology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
kkamagat@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kamagata |
Organization
Juntendo University Graduated School of Medicine
Division name
Department of Radiology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
kkamagat@juntendo.ac.jp
Sponsor or person
Institute
Department of Radiology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
industry to support private universities building up their foundations of strategic research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo hospital ethics committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2014 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016710
