UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013306
Receipt number R000015520
Scientific Title High-resolution MRI neuroimaging of spinal cord in normal subjects as a control of neuroimaging for spinal cord lesions
Date of disclosure of the study information 2014/03/03
Last modified on 2019/09/05 10:35:39

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Basic information

Public title

High-resolution MRI neuroimaging of spinal cord in normal subjects as a control of neuroimaging for spinal cord lesions

Acronym

MRI neuroimaging of spinal cord in normal subjects

Scientific Title

High-resolution MRI neuroimaging of spinal cord in normal subjects as a control of neuroimaging for spinal cord lesions

Scientific Title:Acronym

MRI neuroimaging of spinal cord in normal subjects

Region

Japan


Condition

Condition

normal subjects

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of the present study is to establish the normal value of diffusion tensor imaging and MR spectroscopy of spinal cord in normal subjects.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Diffusion tensor imaging: Apparent diffusion coefficient (ADC) and Fractional anisotropy (FA) will be obtained and establish the normal value.
MR spectroscopy: Metabolites in spinal cord will be measured and establish the normal value.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

40 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

A person without known spinal cord lesions

Key exclusion criteria

pacemaker, claustrophobia, restlessness during MRI

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Masao
Middle name
Last name Koda

Organization

Chiba University Graduate School of Medicine

Division name

Department of Orthopedic Surgery

Zip code

2608670

Address

1-8-1 Inohana, Chuo-Ku, Chiba, Japan

TEL

043-226-2961

Email

masaokod@gmail.com


Public contact

Name of contact person

1st name Shoko
Middle name
Last name Fukuda

Organization

Chiba University Graduate School of Medicine

Division name

Department of Orthopedic Surgery

Zip code

2608670

Address

1-8-1 Inohana, Chuo-Ku, Chiba, Japan

TEL

043-226-2961

Homepage URL


Email

chibaseikei8f@yahoo.co.jp


Sponsor or person

Institute

Chiba University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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

IRB of Chiba University Hospital

Address

1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Tel

043-222-7171

Email

s.fukuda@chiba-u.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

千葉大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 03 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

Completed

Date of protocol fixation

2014 Year 02 Month 14 Day

Date of IRB

2014 Year 02 Month 25 Day

Anticipated trial start date

2014 Year 03 Month 12 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Diffusion tensor imaging and MR spectroscopy will be preformed on spinal cord of normal subjects.


Management information

Registered date

2014 Year 03 Month 01 Day

Last modified on

2019 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015520


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name