UMIN-CTR Clinical Trial

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 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	075-751-3375
Email	murai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Senkei Middle name Last name Ueno
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
Homepage URL
Email	senkei@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	The Committee on Medical Ethics of Kyoto University
Address	Yoshida-Konoe-cho, Kyoto
Tel	075-753-4680
Email	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	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	2016 Year 12 Month 05 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2024 Year 08 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	2016 Year 06 Month 24 Day
Last modified on	2022 Year 06 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026343