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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040130
Receipt No. 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 2021/04/12

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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
Email 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
Email suzuki.kazuko@qst.go.jp

Sponsor
Institute National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Institute
Department

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
Email 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 Enrolling by invitation
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
2021 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045758

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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