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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029875
Receipt No. R000034125
Scientific Title Establishment of normal aging control database of brain MRI and CBF-SPECT making to long-term statistical analysis in regard to the brain and body effect on DPAA exposed person
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/08

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Basic information
Public title Establishment of normal aging control database of brain MRI and CBF-SPECT making to long-term statistical analysis in regard to the brain and body effect on DPAA exposed person
Acronym Making normal aging database of brain MRI and CBF-SPECT
Scientific Title Establishment of normal aging control database of brain MRI and CBF-SPECT making to long-term statistical analysis in regard to the brain and body effect on DPAA exposed person
Scientific Title:Acronym Making normal aging database of brain MRI and CBF-SPECT
Region
Japan

Condition
Condition Normal adult person
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the long-term brain effect of DPAA exposure using MRI and SPECT, we establish normal aging database of CBF-SPECT and brain MRI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain CBF-SPECT, Brain MRI
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Administration of radiopharmaceutical
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subject who inspected it last time as a normal control group
Key exclusion criteria None
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Ishii
Organization University of Tsukuba
Division name Department of Neurology, Clinical Medicine
Zip code
Address 1-1-1 Ten'noudai, Tsukuba, Ibaraki, JAPAN
TEL 029-853-3204
Email kazishii@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Ishii
Organization University of Tsukuba
Division name Department of Neurology, Clinical Medicine
Zip code
Address 1-1-1 Ten'noudai, Tsukuba, Ibaraki, JAPAN
TEL 029-853-3204
Homepage URL
Email kazishii@md.tsukuba.ac.jp

Sponsor
Institute Ministry of the Environment
Institute
Department

Funding Source
Organization Ministry of the Environment
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 12 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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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
2017 Year 11 Month 08 Day
Last modified on
2017 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034125

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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