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
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
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
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
