UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029738
Receipt number R000033977
Scientific Title Normal adult control brain analysis in diffusion kurtosis imaging
Date of disclosure of the study information 2017/10/27
Last modified on 2017/10/27 13:38:01

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Basic information

Public title

Normal adult control brain analysis in diffusion kurtosis imaging

Acronym

Normal adult DKI control analysis

Scientific Title

Normal adult control brain analysis in diffusion kurtosis imaging

Scientific Title:Acronym

Normal adult DKI control analysis

Region

Japan


Condition

Condition

Normal adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study purpose is to make a control data and analytic set of adult to compare with child brain DKI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Age-dependency of DKI signals

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

Device,equipment

Interventions/Control_1

Normal adult MR imaging, one time, appropriately within 10 minutes

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Normal volunteer

Key exclusion criteria

primary illeness

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mamoru Niitsu

Organization

Saitama Medical University

Division name

Radiology

Zip code


Address

Morohongo 38, Moroyama-cho, Iruma-gun, Saitama

TEL

049-276-1317

Email

niitsu@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mamiko Koshiba

Organization

Saitama Medical University

Division name

Pediatrics

Zip code


Address

Morohongo 38, Moroyama-cho, Iruma-gun, Saitama

TEL

049-276-1317

Homepage URL


Email

koshiba@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

2017 Year 10 Month 27 Day


Related information

URL releasing protocol

https://rsna2015.rsna.org/program/?showmodal=2e89286d-1477-4618-bcb0-dbfad94d1a58

Publication of results

Partially published


Result

URL related to results and publications

https://rsna2015.rsna.org/program/?showmodal=2e89286d-1477-4618-bcb0-dbfad94d1a58

Number of participants that the trial has enrolled


Results

DKI hemispheric density quantification in adult was preliminarily confirmed its age-dependency.

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 10 Month 27 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 27 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

2017 Year 10 Month 27 Day

Last modified on

2017 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033977


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name