UMIN-CTR Clinical Trial

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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