UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061535 |
|---|---|
| Receipt number | R000069462 |
| Scientific Title | PET/CT and Machine Learning in Severe Brain Injury: A Single-Center Retrospective Study |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/05/12 10:55:12 |
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Basic information
Public title
Machine learning using combined positron emission tomography and computed tomography for patients with severe brain injury
Acronym
SBI PET/CT-ML Study
Scientific Title
PET/CT and Machine Learning in Severe Brain Injury: A Single-Center Retrospective Study
Scientific Title:Acronym
SBI PET/CT-ML Study
Region
| Japan |
Condition
Condition
Brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess cerebral glucose metabolism in traumatic brain injury using PET/CT and to analyze imaging patterns in relation to clinical symptoms through machine learning based classification.
Basic objectives2
Others
Basic objectives -Others
Exploratory analysis of PET/CT imaging features and their relationship with clinical symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of cerebral glucose metabolism patterns on PET/CT in patients with traumatic brain injury
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with traumatic brain injury who underwent PET/CT imaging at our institution
Imaging data and clinical records available for analysis
Key exclusion criteria
Cases with missing data or images unsuitable for analysis due to artifacts
Cases without ethical approval/consent for retrospective use
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaki |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Neurosurgery
Zip code
2610012
Address
3-30-1 Isobe, Mihama-ku,Chiba-shi, Chiba, Japan
TEL
0432770061
t-yamaki@chiba-ryougo.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Omura |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Medical affairs division
Zip code
2610012
Address
3-30-1 Isobe, Mihama-ku,Chiba-shi, Chiba, Japan
TEL
0432770061
Homepage URL
y-oomura@chiba-ryougo.jp
Sponsor or person
Institute
Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department
Personal name
Funding Source
Organization
Rehabilitation Center for Traumatic Apallics Chiba
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
Rehabilitation Center for Traumatic Apallics Chiba
Address
3-30-1 Isobe, Mihama-ku,Chiba-shi, Chiba, Japan
Tel
0432770061
y-oomura@chiba-ryougo.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
自動車事故対策機構千葉療護センター(千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 12 | 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
135
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, AI-based image analysis methods are applied to FDG-PET images to extract imaging features and derive disease-related indices. The analysis is performed using existing clinical imaging data, and no additional interventions are conducted. Detailed information regarding the AI algorithms and parameters is not disclosed in this registry. The results of the AI analysis will be used for statistical analysis.
Management information
Registered date
| 2026 | Year | 05 | Month | 12 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069462
