UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049061 |
|---|---|
| Receipt number | R000055890 |
| Scientific Title | Inter-scanner dependency of function-related MR imaging |
| Date of disclosure of the study information | 2022/09/29 |
| Last modified on | 2022/09/29 11:08:39 |
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Basic information
Public title
Inter-scanner dependency of function-related MR imaging
Acronym
Inter-scanner dependency of function-related MR imaging
Scientific Title
Inter-scanner dependency of function-related MR imaging
Scientific Title:Acronym
Inter-scanner dependency of function-related MR imaging
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the model dependence of quantitative values of biofunctional information by MRI calculated by morphological images of the head (T1-weighted, T2-weighted, and FLAIR images), diffusion-weighted images, and perfusion images, and to evaluate the degree of difference in quantitative values among different models.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Visual qualitative evaluation and quantitative evaluation of biological functional information in MRI images taken with different devices.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
-Able-bodied persons who have the ability to give consent to participate in this study and who can read and understand the explanatory documents.
-Males 18 years of age or older
(Limitations were established to reduce the influence of gender differences.)
Key exclusion criteria
-Those who have a history of or are complicated by organic cerebral diseases (such as impaired consciousness, head trauma requiring hospitalization, apparent cerebral infarction, cerebral hemorrhage, etc.).
-Those with substance-related disorders (e.g., drug dependence).
-Persons with complications of serious diseases, or persons with a history of such diseases who are judged by the investigators to be inappropriate as subjects of this study.
-Persons with magnetic metals in their bodies (tattoos, tattoos including art makeup, pacemakers, etc.)
-Those who have a strong fear of claustrophobia.
-Other subjects who are judged by the investigators to be inappropriate as research subjects.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kataoka |
Organization
National Institute for Quantum Science and Technology
Division name
Department of Functional Brain Imaging
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-206-3251
kataoka.yuko@qst.go.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Kataoka |
Organization
National Institute for Quantum Science and Technology
Division name
Department of Functional Brain Imaging
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-206-3251
Homepage URL
kataoka.yuko@qst.go.jp
Sponsor or person
Institute
National Institute for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
None
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
National Institute for Quantum Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
Tel
043-206-3251
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
| 2022 | Year | 09 | Month | 29 | 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
| 2022 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-prospective study
Management information
Registered date
| 2022 | Year | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055890
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
