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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025984
Receipt No. R000029874
Scientific Title Evaluation of oxidative stress in patients with neuropsychiatric diseases using PET/MRI imaging
Date of disclosure of the study information 2017/02/03
Last modified on 2019/08/08

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

Condition
Condition Neuropsychiatric diseases
Classification by specialty
Neurology Psychiatry Radiology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate oxidative stress in patients with neuropsychiatric diseases using 64Cu-ATSM PET/MRI imaging.
Basic objectives2 Others
Basic objectives -Others Evaluation of the pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate oxidative stress in patients with neuropsychiatric diseases using 64Cu-ATSM PET/MRI 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 Self control
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 PET/MRI, EEG, Neuropsychological tests
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with neuropsychiatric diseases
2. Healthy volunteers
Key exclusion criteria Subjects that investigators and medical doctors need to exclude
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Masamichi
Middle name
Last name Ikawa
Organization University of Fukui
Division name Department of Neurology, University of Fukui Hospital
Zip code 910-1193
Address 23-3 Matsuoka-Shimoaiduki, Eiheiji, Fukui
TEL 0776-61-3111
Email iqw@u-fukui.ac.jp

Public contact
Name of contact person
1st name Masamichi
Middle name
Last name Ikawa
Organization University of Fukui
Division name Department of Neurology, University of Fukui Hospital
Zip code 910-1193
Address 23-3 Matsuoka-Shimoaiduki, Eiheiji, Fukui
TEL 0776-61-3111
Homepage URL
Email iqw@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization JSPS
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 University of Fukui
Address 23-3 Matsuoka-Shimoaiduki, Eiheiji, Fukui
Tel 0776-61-3111
Email chiken@ml.u-fukui.ac.jp

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 02 Month 03 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 03 Day
Date of IRB
2017 Year 01 Month 23 Day
Anticipated trial start date
2017 Year 02 Month 03 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 03 Day
Last modified on
2019 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029874

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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