UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008229
Receipt No. R000009700
Scientific Title Study of clinical data correlation between liver enhancement and liver function, and time point on hepatocyte phase of gadoxetic acid enhanced MRI
Date of disclosure of the study information 2012/07/01
Last modified on 2016/03/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study of clinical data correlation between liver enhancement and liver function, and time point on hepatocyte phase of gadoxetic acid enhanced MRI
Acronym Gadoxetic Acid Liver-enhanced MRI: Observational Study (GALIREO Study)
Scientific Title Study of clinical data correlation between liver enhancement and liver function, and time point on hepatocyte phase of gadoxetic acid enhanced MRI
Scientific Title:Acronym Gadoxetic Acid Liver-enhanced MRI: Observational Study (GALIREO Study)
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this multi-center, non-interventional study is to investigate between liver enhancement at hepatobiliary phase and hepatic function index in a larger patient population undergoing contrast-enhanced MRI using gadoxetic acid. In addition, it is also intended to investigate predictive factors for liver parenchyma enhancement at hepatobiliary phase. Furthermore, based on these results, the patient population will be stratified according to their hepatic function and time points appropriate for hepatobiliary phase will be investigated in the patient population with good hepatic function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Primary endpoints
(1) Relationship between "sufficient liver enhancement" at hepatobiliary phase and clinical (including Child-Pugh classification, ICG-R15)

Liver-spleen contrast is defined, in accordance with the report by Motosugi et al. as follows: liver-spleen contrast = the signal intensity of the liver / signal intensity of spleen (*)

"Sufficient liver enhancement" is defined, in accordance with the report by Motosugi et al, as follows: liver-spleen contrast calculated in * is > or = 1.5.

It will statistically be investigated if hepatobiliary images at 20 minutes after the administration of gadoxetic acid are associated with "sufficient liver enhancement" or not and their relationship with each parameter of the clinical laboratory test.
Key secondary outcomes (1) Relationship between liver-spleen contrast at hepatobiliary phase and clinical laboratory parameters
(including Child-Pugh classification, ICG-R15)
(2) Comparison of liver-spleen contrast between each time point of hepatobiliary phase
(3) Comparison of lesion-liver contrasts between time points of hepatobiliary phase imaging
(4) Safety endpoints
Safety parameters include evaluation of the general tolerance index reported by patients and doctors, adverse events (AEs) and their types and severity.

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
85 years-old >
Gender Male and Female
Key inclusion criteria (1) Patient, who need EOB enhanced MRI
(2) Clinical examination data can be obtained within one month before EOB enhanced MRI
(3) Less than upper limit of normal serum creatinine level
(4) Less than 100 kg of patient body weight
(5) Consciousness of patient is clear

Key exclusion criteria (1) Patients with contraindications of MRI (such as pacemaker)
(2) Patients with a history of hypersensitivity to gadolinium contrast agent
(3)Patients with bronchial asthma or severe allergic disease
(4) Patients with severe renal dysfunction
(5)Pregnant patients, and patients during lactation
Target sample size 1800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamichi Murakami
Organization Kinki University Faculty of Medicine
Division name Department of Radiology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Okada
Organization Kinki University Faculty of Medicine
Division name Department of Radiology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Homepage URL http://radiol.med.kindai.ac.jp/
Email mokada@radiol.med.kindai.ac.jp

Sponsor
Institute Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 近畿大学医学部附属病院(大阪)  Kinki University Hospital(Osaka)
その他、日本国内およそ60施設が本試験に参加予定。
About 60 institutions in Japan will participate in this study.

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 01 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
We cannot show the result, because of prepublication.
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
2012 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 07 Month 07 Day
Date of closure to data entry
2014 Year 07 Month 20 Day
Date trial data considered complete
2014 Year 07 Month 20 Day
Date analysis concluded
2014 Year 12 Month 24 Day

Other
Other related information Prospective, consecutive,
non-selective, single-arm,
multi-center, non-interventional
study

After starting this study, all patients who need EOB-MRI and who sign
informed consent should consecutively
and non-selectively be enrolled.

Because this study is a
non-interventional and observational
study, the method how to obtain
informed consent follows the rule of
each institution.

Management information
Registered date
2012 Year 06 Month 22 Day
Last modified on
2016 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009700

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.