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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022868
Receipt No. R000026343
Scientific Title Traumatic brain injury and amyloid pathology
Date of disclosure of the study information 2016/09/01
Last modified on 2018/12/26

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Basic information
Public title Traumatic brain injury and amyloid pathology
Acronym Traumatic brain injury and amyloid pathology
Scientific Title Traumatic brain injury and amyloid pathology
Scientific Title:Acronym Traumatic brain injury and amyloid 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 amyloid PET imaging technique.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amyloid 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]FPYBF-2 Amyloid 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 years-old <=
Age-upper limit
65 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
Middle name
Last name Toshiya Murai
Organization Kyoto University
Division name Department of Psychiatry, Graduate School of Medicine
Zip code
Address 54 Kawaharacho, Kyoto, Japan
TEL 075-751-3375
Email murai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiho Ubukata
Organization Kyoto University
Division name Department of Psychiatry, Graduate School of Medicine
Zip code
Address 54 Kawaharacho, Kyoto, Japan
TEL 075-751-4947
Homepage URL
Email ubukata@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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
Address
Tel
Email

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
2016 Year 09 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 24 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026343

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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