UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018154 |
|---|---|
| Receipt number | R000021027 |
| Scientific Title | 11C-acetate PET for Multiple sclerosis |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/07/01 19:25:01 |
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Basic information
Public title
11C-acetate PET for Multiple sclerosis
Acronym
11C-acetate PET for Multiple sclerosis
Scientific Title
11C-acetate PET for Multiple sclerosis
Scientific Title:Acronym
11C-acetate PET for Multiple sclerosis
Region
| Japan |
Condition
Condition
Multiple Sclerosis, NMO
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish 11C-acetate PET as an examination for multiple sclerosis/NMO.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to reach maximam concentration of radioactivity in brain
Key secondary outcomes
Time to reach maximam concentration of radioactivity in blood
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Withdraw blood before and after the injection of 11C-acetate
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20 MS patients who go to department of Neurology of Osaka University Hospital and 10 healthy subjects
Key exclusion criteria
Woman who is pregnant or breast-feeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Nakatsuji |
Organization
Osaka University School of Medicine
Division name
Neurology
Zip code
Address
2-2 Yamada-oka, Suita, Osaka
TEL
06-6879-3571
yuji@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Nakatsuji |
Organization
Osaka University
Division name
Neurology
Zip code
Address
2-2 Yamada-oka, Suita, Osaka
TEL
06-6879-3571
Homepage URL
yuji@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
department of neurology, Osaka university school of medicine
Institute
Department
Personal name
Funding Source
Organization
research glant of Novartis Pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2015 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021027
