UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018190
Receipt number R000019998
Scientific Title Accelerated single breath-hold non-contrast-enhanced MR portography using compressed sensing
Date of disclosure of the study information 2015/07/20
Last modified on 2017/07/12 14:15:44

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Basic information

Public title

Accelerated single breath-hold non-contrast-enhanced MR portography using compressed sensing

Acronym

Accelerated single breath-hold non-contrast-enhanced MR portography using compressed sensing

Scientific Title

Accelerated single breath-hold non-contrast-enhanced MR portography using compressed sensing

Scientific Title:Acronym

Accelerated single breath-hold non-contrast-enhanced MR portography using compressed sensing

Region

Japan


Condition

Condition

healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the performance of single breath-hold non-contrast-enhanced MR portography accelerated with compressed sensing(CS).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison between CS MRI and non-CS MRI

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

Device,equipment

Interventions/Control_1

Both CS MRI and non-CS MRI will be conducted for healthy volunteers only once.

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

Healthy subjects are selected by absence of significant previous clinical history.

Key exclusion criteria

Subjects incompatible to MRI scan. Informed consent not given.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaori Togashi

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Diagnostic Imaging and Nuclear Medicine

Zip code


Address

54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto

TEL

075-751-3760

Email

nmdioffice@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ayako Ono

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Diagnostic Imaging and Nuclear Medicine

Zip code


Address

54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto

TEL

075-751-3760

Homepage URL


Email

onoayako@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2015 Year 07 Month 20 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

2015 Year 07 Month 03 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 20 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

2015 Year 07 Month 04 Day

Last modified on

2017 Year 07 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019998


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name