UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008229 |
|---|---|
| Receipt number | 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 09:11:36 |
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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
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/
mokada@radiol.med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009700
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
