UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022949 |
|---|---|
| Receipt number | R000025337 |
| Scientific Title | Multicenter study of [18F]-THK-5351 PET in tauopathies |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2020/01/30 17:34:59 |
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Basic information
Public title
Multicenter study of [18F]-THK-5351 PET in tauopathies
Acronym
[18F]-THK-5351 PET in tauopathies
Scientific Title
Multicenter study of [18F]-THK-5351 PET in tauopathies
Scientific Title:Acronym
[18F]-THK-5351 PET in tauopathies
Region
| Japan |
Condition
Condition
tauopathy
Classification by specialty
| Neurology | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of Tau PET imaging for diagnosing tauopathies and to differentiate aging and pathological tau accumulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution pattern of [18F]-THK-5351 in each tauopathy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
PET examination
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
| 35 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Clinical suspicious of tauopathy
Key exclusion criteria
#brain infarction, hydrocephalus, metabolic disorder, tumor, inflammation
#claustrophobia
#cardiac pacemaker insertion, metabolic insertion, tatoo
#attending other study including nuclear medicine examination
#decision made by attending physician
#denying to get the results of examinations
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HARUMASA TAKANO |
Organization
National Center of Neurology and Psychiatry
Division name
Integrative Brain Imaging Center
Zip code
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
hrtakano@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HARUMASA TAKANO |
Organization
National Center of Neurology and Psychiatry
Division name
Integrative Brain Imaging Center
Zip code
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
hrtakano@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
The 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 | 07 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 30 | Day |
Last modified on
| 2020 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025337
