UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005401
Receipt number R000006181
Scientific Title Evaluation of effect of chemotherapy for depiction of metastatic liver tumor on gadoxetate disodium enhanced MRI
Date of disclosure of the study information 2011/04/11
Last modified on 2013/05/07 09:26:22

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Basic information

Public title

Evaluation of effect of chemotherapy for depiction of metastatic liver tumor on gadoxetate disodium enhanced MRI

Acronym

Evaluation of effect of chemotherapy on gadoxetate disodium enhanced MRI

Scientific Title

Evaluation of effect of chemotherapy for depiction of metastatic liver tumor on gadoxetate disodium enhanced MRI

Scientific Title:Acronym

Evaluation of effect of chemotherapy on gadoxetate disodium enhanced MRI

Region

Japan


Condition

Condition

metastatic liver tumor

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Breast surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of chamotherapy (espesially Lapatinib) on gadoxetate disodium-enhanced MRI

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To verify the change on enhancement pattern of liver and vessels, and also the change of capability of detection of tumor with gadoxetate disodium-enhanced MRI

Key secondary outcomes



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

Patients with Lapatinib therapy or patients who are scheduled for Lapatinib therapy

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

(a) Patients older than 20-year-old.
(b) Patients with Lapatinib therapy or patients who are scheduled for Lapatinib therapy.
(c) Patients whose body weight is lower than 100kg.
(d) Patients with informed consent.

Key exclusion criteria

(a) Patients who are contraindicated in MRI examination (for example; patients with pace maker and claustrophobia patients).
(b) Patients with history of severe side effect of gadolinium contrast media and gadoxetate disodium.
(c) Patients with poor performance status.
(d) Patients with bronchial asthma.
(e) Patients with severe liver damage (Serum bilirubin > 2.0mg/dL).
(f) Patients with severe kidney damage (eGFR < 30ml/min/1.73m2).
(g) Gravid or lactating patients and patients who may be pregnant.
(h) Patients whom their doctor decide to be inappropriate for this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Awai

Organization

Hiroshima University

Division name

Department of Diagnostic Radiology

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5257

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yuko Nakamura

Organization

Hiroshima University

Division name

Department of Diagnostic Radiology

Zip code


Address


TEL


Homepage URL


Email

yukon@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Bayer Schering Pharma

Organization

Division

Category of Funding Organization

Profit organization

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

広島大学病院


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 11 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

Terminated

Date of protocol fixation

2011 Year 03 Month 07 Day

Date of IRB


Anticipated trial start date

2011 Year 04 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

2011 Year 04 Month 07 Day

Last modified on

2013 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006181


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name