UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001166 |
|---|---|
| Receipt number | 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 18:33:56 |
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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
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
junhashi@rad.med.keio.ac.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001425
