UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047991 |
|---|---|
| Receipt number | R000054668 |
| Scientific Title | Multisite study of diagnostic support application for the brain |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2022/12/13 18:26:26 |
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Basic information
Public title
Multisite study of diagnostic support application for the brain
Acronym
Multisite study of diagnostic support application for the brain
Scientific Title
Multisite study of diagnostic support application for the brain
Scientific Title:Acronym
Multisite study of diagnostic support application for the brain
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
QSM (Quantitative Susceptibility Mapping), which is one of quantitative MRI, and of diagnostic imaging support application, is investigated on degree of correlation against for multiple facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of correlation on QSM value on the ROI, against for multiple facilities, is evaluated.
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
Magnetic Resonance Imaging
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 and Female
Key inclusion criteria
The participant who agrees both MR imaging at the institution and another MR imaging at one of the cooperative institutions.
Key exclusion criteria
The person who has pacemaker, stimulation electrodes, artificial inner ear, and/or artificial middle ear.
The person who is pregnant or is probably pregnant.
The person with art makeup and/or with tattoos.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Gunma Prefectural Collage of Health Sciences
Division name
School of Radiation Technology
Zip code
371-0052
Address
Kamioki-machi, Maebashi, Gunma, 371-0052, Japan
TEL
027-235-1211
ttakahashi@gchs.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Gunma Prefectural Collage of Health Sciences
Division name
School of Radiation Technology
Zip code
371-0052
Address
Kamioki-machi, Maebashi, Gunma, 371-0052, Japan
TEL
027-235-1211
Homepage URL
ttakahashi@gchs.ac.jp
Sponsor or person
Institute
Gunma Prefectural Collage of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Gunma Prefectural Collage of Health Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gunma University Hospital
Isesaki Municipal Hospital
Kiryu Kosei General Hospital
Mihara Memorial Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Prefectural Collage of Health Sciences, Ethics committee
Address
323-1, Kamioki-machi, Maebashi, Gunma, 371-0052, Japan
Tel
027-235-1211
kenkou@gchs.ac.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 | 06 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054668
| 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 |
