UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003079 |
|---|---|
| Receipt number | R000003736 |
| Scientific Title | Assessment of the effect of portal venous embolization by MRI uging liver specificity contrast material |
| Date of disclosure of the study information | 2010/01/25 |
| Last modified on | 2010/01/23 15:56:39 |
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Basic information
Public title
Assessment of the effect of portal venous embolization by MRI uging liver specificity contrast material
Acronym
EOB-PVE
Scientific Title
Assessment of the effect of portal venous embolization by MRI uging liver specificity contrast material
Scientific Title:Acronym
EOB-PVE
Region
| Japan |
Condition
Condition
Hepatobiliary malignancy
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the liver function before and after portal venous embolization using liver specificity contrast material.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time intensity curve of the contrast material of embolized and non-embolized liver.
The level of intensity at the hepatobiliary phase of embolized and non-embolized liver.
Key secondary outcomes
liver function test
blood concentration of primobist
pathological findings of resected specimen
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
| Medicine |
Interventions/Control_1
Injection of EOB-Primovist as the contrast material at the MRI.
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
Inclusion criteria
1. Biliary malignancy, primary liver tumor, metastatic liver tumor
2. Major hepatectomy is necessary to remove the malignancy.
3. Fulfill the criteria to apply portal venous embolization.
4. Informed consent of this trial is necessary.
5. Patient is more than 20 years old.
Key exclusion criteria
Exclusion criteria
1. A patient with hypersensitivity to EOB-Primovist or Gadrinium.
2. A patient with asthma.
3. A patient with sever renal dysfunction.
4. A patient with pregnancy.
5. A woman with breast-feeding.
6. A patient with severe claustrophobia or nyctophobia.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuji Seyama |
Organization
University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Zip code
Address
TEL
03-5800-8654
Homepage URL
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, University of Tokyo,
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 01 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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
Management information
Registered date
| 2010 | Year | 01 | Month | 23 | Day |
Last modified on
| 2010 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003736
