UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050209 |
|---|---|
| Receipt number | R000057179 |
| Scientific Title | Astrogliosis imaging using 18F-THK5351 PET in neurological disorders |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/02/01 14:14:34 |
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Basic information
Public title
Astrogliosis imaging using 18F-THK5351 PET in neurological disorders
Acronym
Astrogliosis imaging in neurological disorders
Scientific Title
Astrogliosis imaging using 18F-THK5351 PET in neurological disorders
Scientific Title:Acronym
Astrogliosis imaging in neurological disorders
Region
| Japan |
Condition
Condition
neurological disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the pathophysiology in neurological disorders using astrogliosis imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
THK5351 uptake
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects who were diagnosed with neurological disorders.
The subjects who can sign informed consent.
Key exclusion criteria
The subjects who cannot undergo MRI.
The subject who have chronic dysfunction in the organs.
Pregnant or woman who has a chance of pregnant.
The subjects who were judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ishibashi |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Neuroimaging
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
ishibashi@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ishibashi |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Neuroimaging
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
0339643241
Homepage URL
ishibashi@pet.tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Institute of Gerontology
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
IRB at Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
0339643241
sato@pet.tmig.or.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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2023 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057179
