UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040130 |
|---|---|
| Receipt number | R000045758 |
| Scientific Title | A study of the association of dopamine D1 and D2 receptor binding potentials in the brain with clinical features of patients with dystonia |
| Date of disclosure of the study information | 2020/04/20 |
| Last modified on | 2023/04/10 09:58:51 |
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Basic information
Public title
A study of the association of dopamine D1 and D2 receptor binding potentials in the brain with clinical features of patients with dystonia
Acronym
A study of the association of dopamine D1 and D2 receptor binding potentials in the brain with clinical features of patients with dystonia
Scientific Title
A study of the association of dopamine D1 and D2 receptor binding potentials in the brain with clinical features of patients with dystonia
Scientific Title:Acronym
A study of the association of dopamine D1 and D2 receptor binding potentials in the brain with clinical features of patients with dystonia
Region
| Japan |
Condition
Condition
dystonia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the mechanisms underlying the pathology and the clinical features of dystonia. For this purpose, we assess the association of the changes of dopamine D1 and D2 receptor binding potentials and structures in the brain with clinical symptoms and functions. We evaluate them by PET with 11C-SCH23390 and 11C-raclopride, MRI for the brain structures, psychological tests for general cognitive functions, and neurological examinations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The associations between dopamine D1 and D2 receptor binding potentials evaluated by PET and clinical features of dystonia
Key secondary outcomes
The associations between dopamine D1 and D2 receptor binding potentials evaluated by PET and brain structures evaluated by MRI of dystonia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET/MRI/psychological batteries/neurological examinations
Interventions/Control_2
PET/MRI/psychological batteries/neurological examinations
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
| 17 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with dystonia
1. 17 years of age or older at the time of obtaining consent
2. patients with dystonia or carriers who have DYT-T gene abnormalities
2) Healthy volunteers
Healthy volunteers who underwent PET scans with 11C-SCH23390 or 11C-raclopride in the 17-005 Study, the 11-023 Study, the 12-003 Study, and the 12-008 Study conducted at National Institutes for Quantum and Radiological Science and Technology and have not refused secondary use of their data at the time of obtaining consent
Key exclusion criteria
1) patients with dystonia
1. Subjects with organic brain complications/disorders
2. Subjects with substance-related disorders
3. Subjects with severe physical complications/disorders or a history of such conditions
4. Subjects with claustrophobia
5. Pregnant, possibly pregnant or lactating women
6. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study
7. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
2) Healthy volunteers
We exclude the data of the healthy volunteers who refused secondary use of their data for another clinical studies at the time of obtaining consent. Under the announcement of the secondary use in the homepage of National Institutes for Quantum and Radiological Science and Technology, we exclude the data of the healthy volunteers who underwent scans or examinations in the studies by 31 December 2019, if they refuse secondary use by 30 June 2020.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kiwamu |
| Middle name | |
| Last name | Matsuoka |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Functional Brain Imaging Research, National Institute of Radiological Sciences
Zip code
263-0024
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
+81-43-206-3251
matsuoka.kiwamu@qst.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Suzuki |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Clinical Research Support Section, National Institute of Radiological Sciences
Zip code
263-0024
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
+81-43-206-3251
Homepage URL
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board, National Institiutes for Quantum and Radiological Sciences and Technology
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
+81-43-206-4706
helsinki@qst.go.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
| 2020 | Year | 04 | Month | 20 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045758
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