UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053354 |
|---|---|
| Receipt number | R000060848 |
| Scientific Title | Collection of diffusion-weighted MR spectroscopy data in healthy volunteers |
| Date of disclosure of the study information | 2024/01/22 |
| Last modified on | 2024/01/12 09:31:10 |
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Basic information
Public title
Collection of diffusion-weighted MR spectroscopy data in healthy volunteers
Acronym
Collection of diffusion-weighted MR spectroscopy data in healthy volunteers
Scientific Title
Collection of diffusion-weighted MR spectroscopy data in healthy volunteers
Scientific Title:Acronym
Collection of diffusion-weighted MR spectroscopy data in healthy volunteers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diffusion-weighted MR spectroscopy (DW-MRS) of brain and spinal cord regions in healthy adult volunteers will be performed using a clinical MR system. Diffusion-weighted imaging will also be performed and combined with the information obtained by DW-MRS to investigate the intracellular and extracellular diffusion characteristics of metabolites in the brain and spinal cord.
Basic objectives2
Others
Basic objectives -Others
Examination of measurement conditions. Obtaining quantitative values and diffusion coefficient values for each metabolite.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of DW-MRS measurement conditions in healthy adults. Obtaining quantitative values and diffusion coefficient values for each metabolite. Investigation of intracellular and extracellular diffusion characteristics and localization of metabolites.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Persons who have the ability to give written consent to participate in this study
2) Persons who are between 40 and 70 years of age at the time of obtaining consent. Gender is not an issue.
3) Persons who have been judged to be in good health by a physician who is a researcher.
Key exclusion criteria
1) Persons with a history of serious physical or brain diseases in the past or at present
2) Drug or alcohol dependence
3) Persons who are ineligible for the MR test (those with magnetic metals in the body (tattoos, intraocular lenses, etc.) or claustrophobia)
4) Pregnant or possibly pregnant
5) Persons of high body weight (over 90 kg)
6) Any other person who is deemed inappropriate as a subject of this study by the physician who is the researcher, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Obata |
Organization
National Institutes for Quantum Science and Technology(QST)
Division name
Department of Molecular Imaging and Theranostics, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-206-3230
obata.takayuki@qst.go.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Obata |
Organization
National Institutes for Quantum Science and Technology(QST)
Division name
Department of Molecular Imaging and Theranostics, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-206-3230
Homepage URL
obata.takayuki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology(QST)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
Tel
043-206-4706
helsinki@qst.go.jp
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
| 2024 | Year | 01 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2024 | Year | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060848
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| Registered date | File name |
| Research case data | |
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