UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013905 |
|---|---|
| Receipt number | R000015872 |
| Scientific Title | Non-Contrast-Enhanced MR Angiography for Selective Visualization of the Hepatic Vein in Living Liver Donors Using MPRAGE on 3T MRI. |
| Date of disclosure of the study information | 2014/05/08 |
| Last modified on | 2016/11/09 15:36:40 |
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Basic information
Public title
Non-Contrast-Enhanced MR Angiography for Selective Visualization of the Hepatic Vein in Living Liver Donors Using MPRAGE on 3T MRI.
Acronym
Visualization of Hepatic Vein in Living Liver Donors with Optimized Liver-Parenchyma-Nulled MPRAGE at 3T.
Scientific Title
Non-Contrast-Enhanced MR Angiography for Selective Visualization of the Hepatic Vein in Living Liver Donors Using MPRAGE on 3T MRI.
Scientific Title:Acronym
Visualization of Hepatic Vein in Living Liver Donors with Optimized Liver-Parenchyma-Nulled MPRAGE at 3T.
Region
| Japan |
Condition
Condition
living liver donors
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of non-contrast-enhanced MR angiography using MPRAGE technique for selective visualization of hepatic vein in living liver donor candidates
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Living Liver Donor Candidates
Key exclusion criteria
1 With a pacemaker
2 With any magnetic metal objects in a body
3 Unable to communicate with others
4 With claustrophobia
5 Pregnant woman
Target sample size
40
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 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3760
nmdioffice@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rikiya Yamashita |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3760
Homepage URL
rickdom@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
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
| 2014 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2014 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study acquiring the new data
Management information
Registered date
| 2014 | Year | 05 | Month | 08 | Day |
Last modified on
| 2016 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015872
