UMIN-CTR Clinical Trial

Basic information
Public title	[123I]-IMP SPECT perfusion brain image study in healthy subjects for establishing normal brain database for statistical analysis.
Acronym	Brain perfusion SPECT image normal database
Scientific Title	[123I]-IMP SPECT perfusion brain image study in healthy subjects for establishing normal brain database for statistical analysis.
Scientific Title:Acronym	Brain perfusion SPECT image normal database
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Neurology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To create a normal database on IMP SPECT image analyzed by spatial statistical methods and create normal database on brain perfusion image.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Improve diagnostic power by perfusion image.
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 Behavior,custom
Interventions/Control_1	Administer [123I]-IMP for diagnostic test.Define normal by phsical exams, neuropsychological tests, blood test (complete blood count, chemistry), brain magnetic resonance imaging.
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	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy subjects who are cognitively normal and has no previous illness that influences brain.
Key exclusion criteria	(1)Pregnant or have chance to be pregnant (2)Cognitively impaired (3)Severe physical illness (4)Prior head injury (5)Diabetes (6)Those who are contraindicated to perform MRI scans (7)Occluded large cerebral artery. (8)Severe ischemic brain change (9)Lacunar stroke > 3mm (10)Brain cysts. (11)Chronic pain (12)Those who does not qualify by the physician.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Kuwabara
Organization	Chiba University Graduate School of Medicine
Division name	Department of Neurology
Zip code	260-8670
Address	1-8-1 Inohana,Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL	043-226-2126
Email	kuwabara-s@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Shigeki Middle name Last name Hirano
Organization	Chiba University Graduate School of Medicine
Division name	Department of Neurology
Zip code	260-8670
Address	1-8-1 Inohana,Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL	043-226-2126
Homepage URL
Email	s_hirano@chiba-u.jp

Sponsor
Institute	Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nihon Medi-Physics, Ltd. Co.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB comittee, Graduate School of Medicine, Chiba University, Japan
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel	043-226-2003
Email	igaku-rinri@office.chiba-u.jp

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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2013 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	No longer recruiting
Date of protocol fixation	2013 Year 05 Month 31 Day
Date of IRB	2013 Year 05 Month 31 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2015 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 06 Month 20 Day
Last modified on	2019 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012886