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


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 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


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

Value
https://center6.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