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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016811
Receipt No. R000019511
Scientific Title Multi-center study of construction of normal database for 123I-ioflupane SPECT
Date of disclosure of the study information 2015/03/16
Last modified on 2018/03/23

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Basic information
Public title Multi-center study of construction of normal database for 123I-ioflupane SPECT
Acronym normal database for 123I-ioflupane SPECT
Scientific Title Multi-center study of construction of normal database for 123I-ioflupane SPECT
Scientific Title:Acronym normal database for 123I-ioflupane SPECT
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Construction of normal database of dopamine transporter density using 123I-ioflupan SPECT in healthy volunteers
Basic objectives2 Others
Basic objectives -Others Correction of SPECT data between scanners
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Specific binding of 123I-ioflupan to dopamine transporter in striatum
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 Administration of radiopharmaceutical
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
30 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria (1) Japanese
(2) 30-90 years old
(3) UPDRS Part III <5
(4)Beck Depression Inventory <10
(5)MOCA-J >=26
(6) Person with the ability to understand and obey the contents of a study
(7)The person who can get consent by a document from the person himself
Key exclusion criteria (1) Neurological abnormality
(2) Dementia by DSM V
(3) Family history for Parkisonism or DLB
(4) Contraindication for MRI
(5) Taking medicine that influence on accumulation of 123I-ioflupan in the brain
(6) REM sleep behavior disorder
(7) Allergy for alcohol or iodide
(8) Pregnant woman, lactating woman and person with a pregnant possibility
(9) Unsuitable subject for this study judged by researchers
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Matsuda
Organization National Center of Neurology and Psychiatry
Division name Integrative Brain Imaging Center
Zip code
Address 4-1-1, Ogawahigashi, Kodaira, Tokyo, Japan
TEL 042-341-2711
Email matsudah@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Matsuda
Organization National Center of Neurology and Psychiatry
Division name Integrative Brain Imaging Center
Zip code
Address 4-1-1, Ogawahigashi, Kodaira, Tokyo, Japan
TEL 042-341-2711
Homepage URL http://www.ncnp.go.jp/ibic/index.html
Email matsudah@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Nihon Medi-Physics
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nakamura Memorial Hospital
Tohoku University
Chiba University
Nippon Medical School
Showa University
Fujita Health Univeristy
Kobe University
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 岩手医科大学(岩手県)
東北大学(宮城県)
千葉大学(千葉県)
国立精神・神経医療研究センター(東京都)
日本医科大学(東京都)
昭和大学(東京都)
藤田保健衛生大学(愛知県)
神戸大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs00259-018-3976-5
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 Main results already published
Date of protocol fixation
2015 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 20 Day
Last follow-up date
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 11 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 16 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019511

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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