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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003249
Receipt No. R000003762
Scientific Title Quantitative analysis of dopamine transporter using PET with [18F]FE-PE2I
Date of disclosure of the study information 2010/02/25
Last modified on 2010/02/24

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Basic information
Public title Quantitative analysis of dopamine transporter using PET with [18F]FE-PE2I
Acronym Quantitative analysis of dopamine transporter using PET with [18F]FE-PE2I
Scientific Title Quantitative analysis of dopamine transporter using PET with [18F]FE-PE2I
Scientific Title:Acronym Quantitative analysis of dopamine transporter using PET with [18F]FE-PE2I
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate a quantification method of [18F]FE-PE2I binding in the human brain
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Binding Potential of dopamine transporter
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 Intravenous injection of [18F]FE-PE2I
PET,MRI
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 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ito
Organization National Institute of Radiological Sciences
Division name Molecular Neuroimaging Group, Molecular Imaging Center
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Sasaki
Organization National Institute of Radiological Sciences
Division name 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 t-sasaki@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 25 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
2010 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 24 Day
Last modified on
2010 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003762

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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