UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of oxidative stress in patients with neurological diseases using PET imaging
Title of the study (Brief title)	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	Masamichi Ikawa
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Second Department of Internal Medicine (Neurology)
Address	23-3 Shimoaiduki, Matsuoka, Eiheiji, Fukui, Japan
TEL	0776-61-3111
Email	iqw@u-fukui.ac.jp

Public contact
Name of contact person	Masamichi Ikawa
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Second Department of Internal Medicine (Neurology)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005823