UMIN-CTR Clinical Trial

Basic information
Public title	PET study of brain tau deposition in traumatic brain injury using [11C]PBB3
Acronym	PET study of brain tau deposition in traumatic brain injury using [11C]PBB3
Scientific Title	PET study of brain tau deposition in traumatic brain injury using [11C]PBB3
Scientific Title:Acronym	PET study of brain tau deposition in traumatic brain injury using [11C]PBB3
Region	Japan

Condition
Condition	Healthy volunteer, Traumatic brain injury (TBI)
Classification by specialty	Neurology Psychiatry Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate relations between brain tau deposition and clinical symptoms of traumatic brain injury using PET with [11C]PBB3.
Basic objectives2	Others
Basic objectives -Others	To investigate relations between brain tau deposition and clinical symptoms of traumatic brain injury using PET with [11C]PBB3.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Distribution volume and binding potential measured by positron emission tomography with [11C]PBB3
Key secondary outcomes	Difference of spatial distribution of [11C]PBB3 and [11C]PIB Correlations between tau deposition and various clinical scales

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
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/neuropsychological batteries/neurological examinations
Interventions/Control_2	PET/MRI/neuropsychological 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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	I. Patients 20 y.o.<=Age<=65 y.o. patients suffering from TBI whose mechanism of injury was specified. II.Healthy volunteers 20 y.o.<=Age<=65 y.o., normal subjects
Key exclusion criteria	I. Patients 1. Subjects without ability to make informed consent 2. Subjects with any psychiatric disorder not due to TBI 3. Subjects with any organic brain disorder not due to TBI 4. Subjects with severe physical complication 5. Subjects with severe claustrophobia 6. Pregnant women 7. Subjects with tattoo 8. Subjects with metallic medical device in the body 9. Subjects who was considered to be inappropriate to participate in the study II. Healthy volunteers 1. Subjects without ability to make informed consent 2. Subjects with any psychiatric disorder 3. Subjects with any organic brain disorder 4. Subjects with severe physical complication 5. Subjects with severe claustrophobia 6. Subjects who has participated in other study in recent 6 months. 7. Pregnant women 8. Subjects with tattoo 9. Subjects with metallic medical device in the body 10. Subjects who was considered to be inappropriate to participate in the study
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Takahata
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Zip code
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	81432063025
Email	takahata.keisuke@qst.go.jp

Public contact
Name of contact person	1st name Middle name Last name Keisuke Takahata
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Zip code
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	81432063025
Homepage URL
Email	takahata.keisuke@qst.go.jp

Sponsor
Institute	National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization	a consignment expense for Molecular Imaging Program on "Research Base for PET diagnosis" from the Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japanese Government
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Keio University School of Medicine
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	2014 Year 04 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	Completed
Date of protocol fixation	2014 Year 03 Month 01 Day
Date of IRB	2013 Year 12 Month 26 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2018 Year 12 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	2014 Year 03 Month 26 Day
Last modified on	2019 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015795