UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014639
Receipt No. R000017031
Scientific Title Creating normal database for statistical imaging analysis (3D-SSP) of brain 123I-IMP SPECT that target normal adult volunteers
Date of disclosure of the study information 2014/07/25
Last modified on 2017/01/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Creating normal database for statistical imaging analysis (3D-SSP) of brain 123I-IMP SPECT that target normal adult volunteers
Acronym Creating normal databese for brain 123I-IMP SPECT
Scientific Title Creating normal database for statistical imaging analysis (3D-SSP) of brain 123I-IMP SPECT that target normal adult volunteers
Scientific Title:Acronym Creating normal databese for brain 123I-IMP SPECT
Region
Japan

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

Objectives
Narrative objectives1 Creating normal database
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain perfusion evaluated by 123I-IMP SPECT
Key secondary outcomes

Base
Study type

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 123I-IMP SPECT
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
90 years-old >
Gender Male and Female
Key inclusion criteria MMSE>27
Written consent
MRI: Within nornal limit
Key exclusion criteria psychiatric disorders
neurological disorders which effect cognitive functions
eplepsy
education attainment =< 6
DSWNH Grade >=2 or PVH Grade >=2
severe complications
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoichiro Kato
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 0333531211
Email katomoto@z7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Tabuchi
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 0333531211
Homepage URL
Email tabuchi@a8.keio.jp

Sponsor
Institute Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
2014 Year 07 Month 25 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 Terminated
Date of protocol fixation
2014 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 08 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
2014 Year 07 Month 24 Day
Last modified on
2017 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017031

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.