UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023241 |
|---|---|
| Receipt number | R000026782 |
| Scientific Title | Research on measurement methods of brain metabolites, glucose etc., using 7T-MRI |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/01/22 08:10:01 |
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Basic information
Public title
Research on measurement methods of brain metabolites, glucose etc., using 7T-MRI
Acronym
Research on measurement methods of brain metabolites using 7T-MRI
Scientific Title
Research on measurement methods of brain metabolites, glucose etc., using 7T-MRI
Scientific Title:Acronym
Research on measurement methods of brain metabolites using 7T-MRI
Region
| Japan |
Condition
Condition
Normal volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate measurement methods of brain metabolites using Chemical Exchange Saturation Transfer imaging and MR spectroscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement between blood metabolite levels and measured concentrations.
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Measure glucose concentration after administratoin of glucose. Other brain metabolites are also measured.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy volunteers who gave written informed consent to this study.
Key exclusion criteria
1. Patients with diabetes mellitus.
2. Contra-indication to MRI examination.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohisa Okada |
Organization
Kyoto University
Division name
Human Brain Research Center
Zip code
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto, JAPAN.
TEL
075-751-3760
tomokada@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Okada |
Organization
Kyoto University
Division name
Human Brain Research Center
Zip code
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto, JAPAN.
TEL
075-751-3760
Homepage URL
tomokada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
METI/JETRO
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Siemens Healthcare K.K.
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
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Glucose concentration changes were observed in the brain using MRS after OGTT fluid intake per os.
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
| 2016 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 20 | Day |
Last modified on
| 2019 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026782
