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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003079
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, University of Tokyo,
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003736

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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