UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025518 |
|---|---|
| Receipt number | R000029306 |
| Scientific Title | Basic research for the clinical application of 18F-THK-5351 |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2019/01/07 09:46:57 |
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Basic information
Public title
Basic research for the clinical application of 18F-THK-5351
Acronym
Basic research for the clinical application of 18F-THK-5351
Scientific Title
Basic research for the clinical application of 18F-THK-5351
Scientific Title:Acronym
Basic research for the clinical application of 18F-THK-5351
Region
| Japan |
Condition
Condition
Alzheimer's disease, Nomal adult
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the distribution of 18F-THK-5351 within human whole body in 18F-THK-5351 PET study.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate the distribution of 18F-THK-5351 within human whole body in 18F-THK-5351 PET study.
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
18F-THK-5351 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
| 20 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent 18F-THK-5351 PET.
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Kato |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Radiological and Medical Laboratory Sciences
Zip code
Address
1-20, Daikominami 1-chome, Higashi-ku, Nagoya
TEL
052-744-2553
katokt@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Kato |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Radiological and Medical Laboratory Sciences
Zip code
Address
1-20, Daikominami 1-chome, Higashi-ku, Nagoya
TEL
052-744-2553
Homepage URL
katokt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
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
| 2017 | Year | 03 | Month | 24 | 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
Completed
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
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029306
