UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025586 |
|---|---|
| Receipt number | 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 | 2026/03/31 23:57:52 |
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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 | Manabu |
| Middle name | |
| Last name | TASHIRO |
Organization
Tohoku University
Division name
Cyclotron and Radioisotope Center
Zip code
9808578
Address
6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Miyagi-ken
TEL
022-795-7797
mtashiro@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | TAKEDA |
Organization
Tohoku University
Division name
Cyclotron and Radioisotope Center
Zip code
9808578
Address
6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Miyagi-ken
TEL
022-795-4438
Homepage URL
clinic_supporter@cyric.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Cyclotron and Radioisotope Center
Institute
Department
Personal name
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
Tohoku University Hospital Ethics Committee
Address
1-1 Seiryo Aobaku-ku Sendai-shi
Tel
022-728-4105
rinri-2@proj.med.tohoku.ac.jp
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
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-16H05385/
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-16H05385/
Number of participants that the trial has enrolled
10
Results
We aimed to establish a method for externally measuring MRS signals derived from drug molecules distributed in the brain from orally administered drugs and tracking the changes in the drug's concentration in the brain. It was also shown that there is a possibility of estimating the concentration of orally administered drugs in the brain using MRS signals derived from certain brain metabolite concentrations measured by MRS.
Results date posted
| 2026 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy volunteers
Participant flow
Based on advertisement
Adverse events
Not particular
Outcome measures
MRS signals and plasma drug concentrations
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 24 | Day |
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
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029434
