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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001166
Receipt No. R000001425
Scientific Title Constructing a Normal Database of Tc-99m-HM-PAO Brain Perfusion SPECT for Statistical Image Analyses
Date of disclosure of the study information 2008/06/01
Last modified on 2008/09/03

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Basic information
Public title Constructing a Normal Database of Tc-99m-HM-PAO Brain Perfusion SPECT for Statistical Image Analyses
Acronym Constructing a Normal Database of Brain Perfusion SPECT
Scientific Title Constructing a Normal Database of Tc-99m-HM-PAO Brain Perfusion SPECT for Statistical Image Analyses
Scientific Title:Acronym Constructing a Normal Database of Brain Perfusion SPECT
Region
Japan

Condition
Condition Normal Volunteers
Classification by specialty
Neurology Psychiatry Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To generate a normal database of brain perfusion SPECT for statistical image analyses in diagnosing dementia
Basic objectives2 Others
Basic objectives -Others To obtain a normal database in each age group
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Normal database of brain perfusion SPECT obtained from normal volunteers whose cognitive function and image findings are judged normal
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Healthy normal volunteers who meet all of the following criteria.
1) Age ranging from 20 to 89 at the time of informed consent
2) No remarkable findings in mental state examinations performed within 3 months after obtaining informed consent
3) No remarkable findings for his (her) age in MRI and SPECT examinations performed within 3 months after obtaining informed consent.
4) The participant himself (herself) can provide written informed consent.
Key exclusion criteria 1) Being pregnant or its possibility, or in the lactation period.
2) The history of alcoholism
3) The history of epilepsy
4) The educational period was less than 6 years
5) The history of neuron or psychiatry diseases affecting cognitive function.
6) Severe complications including liver or renal dysfunction, endocrine diseases etc.
7) Taking drugs affecting brain perfusion or cognitive function
8) Abnormal findings in MRI including brain atrophy, ischenmia,infarction, etc.
9) The presence of arachnoid cysts
10) Heavy smokers (more than 20 cigarettes per day for more than 20 years).
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Hashimoto
Organization School of Medicine, Keio University
Division name Department of Radiology
Zip code
Address 35 Shinanomachi, Shimjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3835
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun Hashimoto
Organization School of Medicine, Keio University
Division name Department of Radiology
Zip code
Address 35 Shinanomachi, Shimjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3835
Homepage URL
Email junhashi@rad.med.keio.ac.jp

Sponsor
Institute School of Medicine, Keio University
Institute
Department

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

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
2008 Year 06 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
Date of protocol fixation
2008 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information Assessment of the relashionships between fidings in brain perfusion SPECT and MRI/cognicitve function test results

Management information
Registered date
2008 Year 05 Month 27 Day
Last modified on
2008 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001425

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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