UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029531 |
|---|---|
| Receipt number | R000033743 |
| Scientific Title | Longitudinal study for severe traumatic head injury patients by positron emission tomography/computed tomography |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/10/16 15:00:40 |
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Basic information
Public title
Longitudinal study for severe traumatic head injury patients by positron emission tomography/computed tomography
Acronym
Longitudinal PET/CT study for severe head injury patients
Scientific Title
Longitudinal study for severe traumatic head injury patients by positron emission tomography/computed tomography
Scientific Title:Acronym
Longitudinal PET/CT study for severe head injury patients
Region
| Japan |
Condition
Condition
Traumatic head injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine longitudinal brain metabolism of severe head injury patients by PET/CT
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of glucose and amino acid metabolism in brain
Key secondary outcomes
Clinical symptoms/ Neurophysiological examinations/ Radiological examinations/ Blood examinations
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
18F-FDG-PET/CT/11C Methionine-PET
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subjects who admitted in Chiba Ryogo Center by the cause of severe traumatic head injury
2.Subjects who have medical stability and can perform examinations safely
3.Subjects who have provide informed consent by themselves or their family and adhere to the protocol
Key exclusion criteria
1.Subjects who have medical instability and cannot perform examinations safely
2.Subjects who cannot provide informed consent and adhere to the protocol
3.Subjects who are judged as not suitable for participation in this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaki |
Organization
Chiba Ryogo Center
Division name
Neurosurgery & PET imaging division
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, 261-0012, Japan
TEL
+81-43-277-0061
t-yamaki@chiba-ryougo.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaki |
Organization
Chiba Ryogo Center
Division name
Neurosurgery & PET imaging division
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, 261-0012, Japan
TEL
+81-43-277-0061
Homepage URL
t-yamaki@chiba-ryougo.jp
Sponsor or person
Institute
Chiba Ryogo Center
Institute
Department
Personal name
Funding Source
Organization
Chiba Ryogo Center
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 Ryogo Center
Address
3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba
Tel
043-277-0061
takahito-seki@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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2007 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ongoing
Management information
Registered date
| 2017 | Year | 10 | Month | 12 | Day |
Last modified on
| 2019 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033743
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/04/15 | 20180415Behavioral disorder UMIN CTR 26 patients retrospective data.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
