UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002630
Receipt number R000003189
Scientific Title In vivo analysis for optimization of dynamic MRI using Gd-EOB-DTPA
Date of disclosure of the study information 2009/11/01
Last modified on 2012/11/27 09:19:31

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Basic information

Public title

In vivo analysis for optimization of dynamic MRI using Gd-EOB-DTPA

Acronym

In vivo analysis of dynamic MRI

Scientific Title

In vivo analysis for optimization of dynamic MRI using Gd-EOB-DTPA

Scientific Title:Acronym

In vivo analysis of dynamic MRI

Region

Japan


Condition

Condition

None

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA) is one of the commercially available hepatobiliary magnetic resonance (MR) that distribule both extracellular and hepatocyte. Recommended dose of Gd-EOB-DTPA is half of the ectracellular agents. Therefore, image quality of dynamic MRI using conventional injection method sometimes degrades. The purpose of this study is to clarify the optimal method of dynamic MRI using Gd-EOB-DTPA by comparison between conventional and new injection methods.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of the signal intensity of dynamic MRI that will be performed by conventional method of exrtacellular agent and by new method of Gd-EOB-DTPA.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Group A: extracellular agent, conventional method

Interventions/Control_2

Group B: Gd-EOB-DTPA, conventional method

Interventions/Control_3

Group C: Gd-EOB-DTPA, half injection rate

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

normal volunteer

Key exclusion criteria

the person who are under treatment for any disease

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masumi Kadoya

Organization

Shinshu University, School of Medicine

Division name

Radiology

Zip code


Address

3-1-1 Asahi, Matsumoto city

TEL

0263-37-2650

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasunari Fujinaga

Organization

Shinshu University Hospital

Division name

Radiology

Zip code


Address


TEL

0263-37-2650

Homepage URL


Email



Sponsor or person

Institute

Shinshu University

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

2009 Year 11 Month 01 Day


Related information

URL releasing protocol

http://link.springer.com/

Publication of results

Published


Result

URL related to results and publications

http://link.springer.com/

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

2009 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2010 Year 06 Month 01 Day

Date of closure to data entry

2010 Year 06 Month 01 Day

Date trial data considered complete

2010 Year 06 Month 01 Day

Date analysis concluded

2012 Year 06 Month 10 Day


Other

Other related information



Management information

Registered date

2009 Year 10 Month 14 Day

Last modified on

2012 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003189


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name