UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005626 |
|---|---|
| Receipt number | R000006648 |
| Scientific Title | Clinical study using positron emission tomography(PET) |
| Date of disclosure of the study information | 2011/05/22 |
| Last modified on | 2019/03/12 21:56:31 |
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Basic information
Public title
Clinical study using positron emission tomography(PET)
Acronym
PET imaging of Aquapolin-1,4 using TGN020
Scientific Title
Clinical study using positron emission tomography(PET)
Scientific Title:Acronym
PET imaging of Aquapolin-1,4 using TGN020
Region
| Japan |
Condition
Condition
brain tumor,epilepsy,multiple sclerosis, neuromyelitis,Duchenne musclar dystrophy,Alzheimer's disease,Down Syndrome,Hydrocephalus
Classification by specialty
| Neurology | Pediatrics | Ophthalmology |
| Neurosurgery | Adult | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
direct in vivo PET imaging of AQP1,4 distribution
Basic objectives2
Others
Basic objectives -Others
A search of the location of abnormality associated with the distribution of AQP1,4
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
in vivo imaging of the distribution of AQP1,4 and clinical condition elucidation of the disease group associated with AQP1,4
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 | Device,equipment |
Interventions/Control_1
Image analysis for the distribution of AQP1,4 between normalvolunteer and associated patients (once administration)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy adult volunteer and patients of disease associated with AQP4
Key exclusion criteria
The person that an examination for 30-minute imaging is impossible
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nakada |
Organization
University of Niigata
Division name
Center for Integrated Human Brain Science
Zip code
951-8585
Address
Asahimatchi 1-757,Chuo-ku,Niigata
TEL
025-227-0683
tnakada@bri.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
University of Niigata
Division name
Center for Integrated Human Brain Science
Zip code
951-8585
Address
Asahimatchi 1-757,Chuo-ku,Niigata
TEL
025-227-0683
Homepage URL
yuji-s@bri.niigata-u.ac.jp
Sponsor or person
Institute
Center for Integrated Human Brain Science, Brain Research Institute, University of Niigata
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sport, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Niigata
Address
Asahimatchi 1-757,Chuo-ku,Niigata
Tel
025-227-2006
shomu@med.niigata-u.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
| 2011 | Year | 05 | Month | 22 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006648
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
