UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007160
Receipt number 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 11:42:01

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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 or person

Institute

University of Fukui

Institute

Department

Personal name



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

Value
https://center6.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