UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013517 |
|---|---|
| Receipt number | R000015795 |
| Scientific Title | PET study of brain tau deposition in traumatic brain injury using [11C]PBB3 |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2019/09/30 10:35:52 |
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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
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
takahata.keisuke@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015795
