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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005255
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Molecular Imaging Center, National Institute of Radiological Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006250

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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