UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052816 |
|---|---|
| Receipt number | R000060279 |
| Scientific Title | In vivo imaging of microglial activation on autism spectrum disorder: positron emission tomography study |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2023/11/16 15:09:40 |
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Basic information
Public title
Microglial activation on autism spectrum disorder: positron emission tomography study
Acronym
Microglial activation on autism spectrum disorder by PET
Scientific Title
In vivo imaging of microglial activation on autism spectrum disorder: positron emission tomography study
Scientific Title:Acronym
In vivo imaging of microglial activation on autism spectrum disorder: positron emission tomography study
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate microglial activation differs in indivdualds with ASD compared with model animals.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The availability of PET tracer
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 and Female
Key inclusion criteria
Individuals with ASD or typically developing subjects participated in the [11C]PK11195 PET study held by Department of Psychiatry in Hamamatsu University School of Medicine from 1st March 1997 to 31th March 2023.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Yamasue |
Organization
Hamamatsu University School of Medicine
Division name
Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu,Shizuoka, Japan.
TEL
0534352295
yamasue@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Yokokura |
Organization
Hamamatsu University School of Medicine
Division name
Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu,Shizuoka, Japan.
TEL
0534352295
Homepage URL
ykkr@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu Medical Photonics Foundation, National Center of Neurology and Psychiatry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu,Shizuoka, Japan.
Tel
053-435-2680
rinri@hama-med.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
| 2023 | Year | 11 | Month | 20 | 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
| 2023 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060279
