UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031787 |
|---|---|
| Receipt number | R000036285 |
| Scientific Title | In vivo quantification of the cerebral monoacylglycerol lipase using [18F]T-401 |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/12/04 10:12:45 |
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Basic information
Public title
In vivo quantification of the cerebral monoacylglycerol lipase using [18F]T-401
Acronym
In vivo quantification of the cerebral monoacylglycerol lipase using [18F]T-401
Scientific Title
In vivo quantification of the cerebral monoacylglycerol lipase using [18F]T-401
Scientific Title:Acronym
In vivo quantification of the cerebral monoacylglycerol lipase using [18F]T-401
Region
| Japan |
Condition
Condition
Normal healthy controls
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimation of efficacy and safety of [18F]T-401 PET to quantify monoacylglycerol lipase (MAGL) density in human brain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics and distribution volume of[18F]T-401 in human brain.
Effective dose of [18F]T-401 in human
Key secondary outcomes
Relationship between the density of MAGL and cognitive function
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]T401 PET
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male
Key exclusion criteria
1. Subjects who do not have ability to make informed consent.
2. Subjects with any psychiatric disorder or subjects with severe physical complication
3. Subjects who currently smokes
4. Subjects with any organic brain disorder
5. Subjects with metallic medical device in the body
6. Subjects with tattoo
7. Subjects with severe claustrophobia
8. Subjects with a history of allergy to heparin and local anesthetics.
9. Subjects who has participated in other study in recent 6 months
10. Subjects who has participated in blood donation in recent 12 weeks
11. Subjects who is considered to be inappropriate to participate in the study
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Takahata |
Organization
National Institute of Radiological Sciences (NIRS), National Institutes for Quantum and Radiological Science and Technology (QST)
Division name
Department of Functional Brain Imaging Research
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 (NIRS), National Institutes for Quantum and Radiological
Division name
Department of Functional Brain Imaging Research
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
Department of Functional Brain Imaging Research
National Institute of Radiological Sciences
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Department of Functional Brain Imaging Research
National Institute of Radiological Sciences
National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2018 | 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
| 2018 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 19 | 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
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036285
