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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031787
Receipt No. 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

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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
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 (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
Email takahata.keisuke@qst.go.jp

Sponsor
Institute Department of Functional Brain Imaging Research
National Institute of Radiological Sciences
National Institutes for Quantum and Radiological Science and Technology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036285

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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