UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011939 |
|---|---|
| Receipt number | R000013940 |
| Scientific Title | evaluation of brain water flow by [15O]-H2O PET |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2023/10/17 17:12:36 |
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Basic information
Public title
evaluation of brain water flow by [15O]-H2O PET
Acronym
brain water flow by [15O]-H2O PET
Scientific Title
evaluation of brain water flow by [15O]-H2O PET
Scientific Title:Acronym
brain water flow by [15O]-H2O PET
Region
| Japan |
Condition
Condition
healthy adult volunteer
hydrocephalus
Alzheimer disease
MCI
Down Syndrome
Moyamoya disease
Classification by specialty
| Neurology | Pediatrics | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
evaluation of water distribution in each disease
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
detect the changes of water distribution in each disease
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
| Other |
Interventions/Control_1
MRI/CT/clinical 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteers between 20 and 80 years cognitive normal subjects without severe physical complication
patients with Alzheimer disease or hydrocephalus diagnosis
Key exclusion criteria
exclude the patients who are recognized as inadequate patients by doctors with responsibility in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nakada |
Organization
University of Niigata,
Brain Research Institute
Division name
Center for Integrated Human Brain Science
Zip code
951-8585
Address
Asahimachi 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, Brain Research Institute
Division name
Center for Integrated Human Brain Science
Zip code
951-8585
Address
Asahimachi 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
grant from Ministry of Education, Culture, Sports, Science
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
University of Niigata
Address
Asahimachi 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
| 2013 | Year | 10 | 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
97
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently submitting a paper on the results.
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
| 2013 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2006 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013940
