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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007160
Receipt No. R000005823
Scientific Title Evaluation of oxidative stress in patients with neurological diseases using PET imaging
Date of disclosure of the study information 2012/02/01
Last modified on 2017/02/03

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Basic information
Public title Evaluation of oxidative stress in patients with neurological diseases using PET imaging
Acronym Oxidative stress imaging in patients with neurological diseases
Scientific Title Evaluation of oxidative stress in patients with neurological diseases using PET imaging
Scientific Title:Acronym Oxidative stress imaging in patients with neurological diseases
Region
Japan

Condition
Condition neurological diseases
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate regional oxidative stress in patients with neurological diseases using 62Cu-ATSM-PET imaging.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 62Cu-ATSM-PET imaging
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 Device,equipment
Interventions/Control_1 62Cu-ATSM-PET
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 1. Patients with neurological diseases
2. Healthy volunteers
Key exclusion criteria Subjects that investigators and medical doctors need to exclude.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamichi Ikawa
Organization Faculty of Medical Sciences, University of Fukui
Division name Second Department of Internal Medicine (Neurology)
Zip code
Address 23-3 Shimoaiduki, Matsuoka, Eiheiji, Fukui, Japan
TEL 0776-61-3111
Email iqw@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masamichi Ikawa
Organization Faculty of Medical Sciences, University of Fukui
Division name Second Department of Internal Medicine (Neurology)
Zip code
Address 23-3 Shimoaiduki, Matsuoka, Eiheiji, Fukui, Japan
TEL 0776-61-3111
Homepage URL
Email iqw@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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
2012 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2011 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
2012 Year 01 Month 30 Day
Last modified on
2017 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005823

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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