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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025586
Receipt No. R000029434
Scientific Title Measurement of intracerebral drug concentration using magnetic resonance spectroscopy (MRS)
Date of disclosure of the study information 2017/01/10
Last modified on 2019/01/27

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Basic information
Public title Measurement of intracerebral drug concentration using magnetic resonance spectroscopy (MRS)
Acronym Brain drug concentration measurement with MRS
Scientific Title Measurement of intracerebral drug concentration using magnetic resonance spectroscopy (MRS)
Scientific Title:Acronym Brain drug concentration measurement with MRS
Region
Japan

Condition
Condition heanlth vonlunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Purpose of this study is to measure the intracerebral concentration of orally-administered drugs in healthy volunteers using PET/MR scanner (especially using an MRS function).
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes peak information (Hz) of orally-administered drugs
Key secondary outcomes subjective felleing of study participants

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Following oral administration of acetoaminophen 300 mg, brain NMR signals are observed using MRS.
Interventions/Control_2 Following oral administration of diphenhydramine 50 mg, brain NMR signals are observed using MRS.
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
50 years-old >=
Gender Male
Key inclusion criteria 1
Key exclusion criteria 1
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu TASHIRO
Organization Tohoku University
Division name Cyclotron and Radioisotope Center
Zip code
Address 6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Miyagi-ken
TEL 022-795-7797
Email mtashiro@m.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuko TAKEDA
Organization Tohoku University
Division name Cyclotron and Radioisotope Center
Zip code
Address 6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Miyagi-ken
TEL 022-795-4438
Homepage URL
Email clinic_supporter@cyric.tohoku.ac.jp

Sponsor
Institute Tohoku University
Cyclotron and Radioisotope Center
Institute
Department

Funding Source
Organization JSPS (Japan Society for the promotion of science)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Advanced clinical research center, Fukushima prefectural Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 2016-2-53
Org. issuing International ID_1 Tohoku University Hospital clinical research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東北大学サイクロトロン・RIセンター

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 10 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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2018 Year 02 Month 25 Day
Date of closure to data entry
2018 Year 02 Month 25 Day
Date trial data considered complete
2019 Year 01 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 09 Day
Last modified on
2019 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029434

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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