UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detectability of changes in dopamine D2 receptor binding measured with dual-bolus injections of [11C]raclopride
Title of the study (Brief title)	Detectability of changes in dopamine D2 receptor binding by 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 changes in dopamine D2 receptor binding between resting and activated state 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	Changes in binding potential of dopamine D2 receptors due to neuropsychological tasks
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 -Serious medical illness -Within 6 months after the last scan involving radiation exposure
Target sample size	10

Research contact person
Name of lead principal investigator	Yoko Ikoma
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-382-3700
Email	ikoma@nirs.go.jp

Public contact
Name of contact person	Yoko Ikoma
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-382-3700
Homepage URL
Email	ikoma@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)

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	2014 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 07 Day
Anticipated trial start date	2014 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 17 Day
Last modified on	2016 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015707