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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008221
Receipt No. R000009541
Scientific Title Reliability and reproducibility of dopamine D2 receptor binding measured with dual-bolus injections of [11C]raclopride
Date of disclosure of the study information 2012/07/01
Last modified on 2014/12/22

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Basic information
Public title Reliability and reproducibility of dopamine D2 receptor binding measured with dual-bolus injections of [11C]raclopride
Acronym Reliability of [11C]raclopride binding with dual-bolus injections
Scientific Title Reliability and reproducibility of dopamine D2 receptor binding measured with dual-bolus injections of [11C]raclopride
Scientific Title:Acronym Reliability of [11C]raclopride binding with dual-bolus injections
Region
Japan

Condition
Condition Healthy male adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate reliability and reproducibility of dopamine D2 receptor binding measured with dual-bolus injections of [11C]raclopride in the brain of healthy male adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Binding potentials and intra-subject variations
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
Interventions/Control_1 Intravenous injection of [11C]raclopride 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
-Within 6 months after the last injection of radioisotopes
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Ikoma
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Institute of Radiological Sciences
Division name A Planning Department study ethic plan support room
Zip code
Address
TEL
Homepage URL
Email helsinki@nirs.go.jp

Sponsor
Institute 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

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
2012 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 Completed
Date of protocol fixation
2012 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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
2012 Year 06 Month 20 Day
Last modified on
2014 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009541

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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