UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041868 |
|---|---|
| Receipt number | R000047796 |
| Scientific Title | Traumatic brain injury and Tau pathology |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/09/23 15:14:46 |
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Basic information
Public title
Traumatic brain injury and Tau pathology
Acronym
Traumatic brain injury and Tau pathology
Scientific Title
Traumatic brain injury and Tau pathology
Scientific Title:Acronym
Traumatic brain injury and Tau pathology
Region
| Japan |
Condition
Condition
Traumatic brain injury
Classification by specialty
| Psychiatry | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the pathological changes using tau PET imaging technique.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tau deposition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
[18F]PM-PBB3 Tau imaging
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
| 16 | months-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with traumatic brain injury
Key exclusion criteria
claustrophobia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Murai |
Organization
Kyoto University
Division name
Department of Psychiatry, Graduate School of Medicine
Zip code
606-8507
Address
54 Kawaharacho, Kyoto, Japan
TEL
075-751-4947
murai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Ubukata |
Organization
Kyoto University
Division name
Medical Innovation Center Kyoto University Graduate School of Medicine
Zip code
606-8507
Address
53 Kawaharacho, Kyoto, Japan
TEL
075-366-7417
Homepage URL
ubukata@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiga Medical Center research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Committee on Medical Ethics of Kyoto University
Address
Yoshida-Konoe-cho, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2020 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | 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 | 09 | Month | 23 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047796
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
