UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005255 |
|---|---|
| Receipt number | R000006250 |
| Scientific Title | Reproducibility of dopamine synthesis capacity measured with [11C]DOPA and dopamine transporter binding measured with [18F]FE-PE2I using positron emission tomography |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2012/09/18 13:24:04 |
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Basic information
Public title
Reproducibility of dopamine synthesis capacity measured with [11C]DOPA and dopamine transporter binding measured with [18F]FE-PE2I using positron emission tomography
Acronym
Reproducibility of [11C]DOPA uptake and [18F]FE-PE2I binding
Scientific Title
Reproducibility of dopamine synthesis capacity measured with [11C]DOPA and dopamine transporter binding measured with [18F]FE-PE2I using positron emission tomography
Scientific Title:Acronym
Reproducibility of [11C]DOPA uptake and [18F]FE-PE2I binding
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine reproducibility of dopamine synthesis capacity measured with [11C]DOPA and dopamine transporter binding measured with [18F]FE-PE2I binding using positron emission tomography in the brain of healthy male adults.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra-subject variations of dopamine transporter binding
Key secondary outcomes
Intra-subject variations of dopamine synthesis capacity
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
Intravenous injection of [11C]DOPA and [18F]FE-PE2I for positron emission tomography.
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male subjects who have the ability to provide informed consent
Key exclusion criteria
-Psychiatric disorders including drug dependence
-Serious medical illness
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
National Institute of Radiological Sciences
Division name
Clinical Neuroimaging Team, Molecular Neuroimaging Group, Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555,JAPAN
TEL
043-206-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
Clinical Neuroimaging Team, Molecular Neuroimaging Group, Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555,JAPAN
TEL
043-206-3251
Homepage URL
Sponsor or person
Institute
Molecular Imaging Center, National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Self funding
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
独立行政法人 放射線医学総合研究所
National Institute of Radiological Sciences
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 16 | Day |
Last modified on
| 2012 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006250
