UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032927 |
|---|---|
| Receipt number | R000037521 |
| Scientific Title | The observation study in pediatric brain MR Images |
| Date of disclosure of the study information | 2018/06/15 |
| Last modified on | 2026/07/18 11:28:38 |
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Basic information
Public title
The observation study in pediatric brain MR Images
Acronym
The observation study in pediatric brain MR Images
Scientific Title
The observation study in pediatric brain MR Images
Scientific Title:Acronym
The observation study in pediatric brain MR Images
Region
| Japan |
Condition
Condition
Congenital or acquired morphological abnormalities in CNS
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The establish of quantitative analysis in pediatric brain MR images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation of quantitative values in brain MR images with clinical factors (age, sex, diagnosis, prognosis)
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
| 1 | years-old | < |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases under 18 years old with congenital or acquired CNS morphological abnormalities, who visited Chiba University Hospital since June 2000. Patients with normal MRI also will be enrolled to be analyzed as normal controls.
Key exclusion criteria
Cases with poor MR imaging conditions
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Shiohama |
Organization
Chiba University Hospital
Division name
Department of Pediatrics
Zip code
2608670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432227171
asuha_hare@chiba-u.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Shiohama |
Organization
Chiba University Hospital
Division name
Department of Pediatrics
Zip code
2608670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432227171
Homepage URL
asuha_hare@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
Inohana1-8-1, Chuo-ku, Chibashi
Tel
043-222-7171
inohana-rinri@chiba-u.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
| 2018 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.ho.chiba-u.ac.jp/dept/pediatrics/research/rinsho-kenkyu/
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2075-4418/13/17/2774
Number of participants that the trial has enrolled
846
Results
This study aimed to provide across-site normal reference values of global and regional brain volumes for each sex and age group in children and adolescents. We collected brain MRI examinations of 846 neurotypical participants aged 6.0-17.9 years (339 male and 507 female participants) comprising healthy volunteers or neurotypical patients. Regional-based analysis using the CIVET pipeline provided regional brain volumes, and the measurements were across-site combined using ComBat-GAM harmonization.
Results date posted
| 2026 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 27 | Day |
Baseline Characteristics
846 neurotypical participants aged 6.0-17.9 years (339 male and 507 female participants) from 5 institutions comprising healthy volunteers or neurotypical patients without neurological disorders, neuropsychological disorders, or epilepsy.
Participant flow
Patients of institutions or healthy volunteer
Adverse events
No paticulary
Outcome measures
Brain morphologic metrics using brain MRI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will start after enrolling to UMIN-CTR.
Management information
Registered date
| 2018 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037521
