UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021819 |
|---|---|
| Receipt number | R000025151 |
| Scientific Title | [18F]THK-5351 PET imaging of tau deposits in neurological disorders |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2018/07/14 16:42:44 |
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Basic information
Public title
[18F]THK-5351 PET imaging of tau deposits in neurological disorders
Acronym
[18F]THK-5351 PET imaging in neurological disorders
Scientific Title
[18F]THK-5351 PET imaging of tau deposits in neurological disorders
Scientific Title:Acronym
[18F]THK-5351 PET imaging in neurological disorders
Region
| Japan |
Condition
Condition
corticobasal syndrome, other neurodegenerative disorders, and normal volunteers
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Utility evaluation of in vivo visualization of tau deposition by [18F]THK-5351 PET in corticobasal syndrome and other neurodegenerative disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
[18F]THK-5351 uptake in frontal and parietal cortexes of corticobasal syndrome
Key secondary outcomes
[18F]THK-5351 uptake in subcortical white matter or brainstem of corticobasal syndrome
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
| Other |
Interventions/Control_1
After injecting 185 MBq of 18F-THK5351, PET images were obtained and were used for the evaluation of group differences.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Probable CBS are diagnosed based on the modified Cambridge criteria.
2) Written informed consent are obtained from each patient or their guardians after being given a complete description of the study.
Key exclusion criteria
1) neuropsychiatric disorder except for corticobasal syndrome
2) severe cardiovascular disease or liver dysfunction
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kikuchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7189
akikuchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Kikuchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7189
Homepage URL
akikuchi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 07 | Day |
Last modified on
| 2018 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025151
