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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003097
Receipt No. R000003757
Scientific Title Construction of a database for normal cerebral blood flow images using 123I-IMP SPECT
Date of disclosure of the study information 2010/02/01
Last modified on 2014/07/28

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Basic information
Public title Construction of a database for normal cerebral blood flow images using 123I-IMP SPECT
Acronym Construction of a database for normal cerebral blood flow images
Scientific Title Construction of a database for normal cerebral blood flow images using 123I-IMP SPECT
Scientific Title:Acronym Construction of a database for normal cerebral blood flow images
Region
Japan

Condition
Condition cerebrovascular disorder, neurodegenerative disease, epilepsy, etc.
Classification by specialty
Neurology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To construct a database for cerebral blood flow images in normal subjects using a new SPECT machine introduced in Kyoto University Hospital and to evaluate their distribution patterns.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Regional cerebral blood flow images by 123I-IMP SPECT
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 30 minutes SPECT acquisition 5 minutes after injection of 123I-IMP (167MBq)
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
60 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1. Healthy subjects
2. Subjects who agree the purpose and procedure of the study with the paper agree
Key exclusion criteria 1. Subjects with a past history of central nervous system disorders
2. Subjects with MMSE (Mini-mental state examination) less or equal 24
3. Subjects who have difficulty in acquiring SPECT
4. Subjects who have difficulty in acquiring MRI revealed by a MRI questionnaire
5. Subjects with neurological signs (hemiparesis, extrapyramidal sign, bulbar palsy, motor ataxia, oculomotor disorder, aphasia, apraxia, agnosia, hemispatial neglect, convulsion, etc.)
6. Subjects with critical illness (malignant tumor, heart failure, liver failure, renal failure, endocrine disease, etc.)
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenao Fukuyama
Organization Kyoto University Graduate School of Medicine
Division name Human Brain Research Center
Zip code
Address Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Graduate School of Medicine
Division name Human Brain Research Center
Zip code
Address
TEL 075-751-3695
Homepage URL
Email

Sponsor
Institute Human Brain Research Center
Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization National Treasury
Organization
Division
Category of Funding Organization Other
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
2010 Year 02 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 Terminated
Date of protocol fixation
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 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
2010 Year 01 Month 26 Day
Last modified on
2014 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003757

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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