UMIN-CTR Clinical Trial

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	sm-kenkyusien@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	Partially published

Result
URL related to results and publications	https://doi.org/10.3390/antiox11051022
Number of participants that the trial has enrolled	50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 05 Month 22 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 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	2022 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029874