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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002630
Receipt No. 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

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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
Institute Shinshu University
Institute
Department

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
URL(English) https://upload.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


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