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Recruitment status Terminated
Unique ID issued by UMIN UMIN000004103
Receipt No. R000004691
Scientific Title Investigation into Optimal Administration of Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for Hepatocellular Carcinoma
Date of disclosure of the study information 2010/08/30
Last modified on 2014/03/03

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Basic information
Public title Investigation into Optimal Administration of Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for Hepatocellular Carcinoma
Acronym Investigation into Optimal Administration of Ga-EOB-DTPA and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for HCC
Scientific Title Investigation into Optimal Administration of Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for Hepatocellular Carcinoma
Scientific Title:Acronym Investigation into Optimal Administration of Ga-EOB-DTPA and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for HCC
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation into optimal arterial phase of dynamic liver MRI with Gd-EOB-DTPA
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We make time intensity curves of tumor, parenchyma of liver and aorta in each way of administration and also investigate these data.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Duration:the day of MRI examination.
All fluid (EOB + saline):0.5ml per 1kg body weight, using EOB undiluted.
Interventions/Control_2 Duration:the day of MRI examination.
All fluid (EOB + saline):0.5ml per 1kg body weight, using EOB with doubled dilution.
Interventions/Control_3 Duration:the day of MRI examination.
All fluid (EOB + saline):1ml per 1kg body weight, using EOB undiluted.
Interventions/Control_4 Duration:the day of MRI examination.
All fluid (EOB + saline):1ml per 1kg body weight, using EOB with doubled dilution.
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 1) Patients who were diagnosed as hepatocellular carcinoma by contrast enhanced CT and was scheduled for surgical resection.
2) Patients who can undergo EOB-MRI within one month from contrast enhanced CT.
3) Patients who announced voluntary consent through their writing after a full explanation of the study and a enough understanding.
4) Patients over 20 years old at the time of obtaining informed consent.
Key exclusion criteria 1) Patients with lesions that are received prior RFA or TAE treatment.
2) Patients with a history of hypersensitivity to gadolinium-based contrast agent or this test drug.
3) Patients who have asthma.
4) Patients with severe kidney disease. (eGFR<30mL/min/1.73square meter or serum Cr>1.5mg/dl)
5) Patients during pregnancy or potential pregnancy.
6) Patients who are lactating women.
7) Patients who have advanced nyctophobia cabin.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Akahane
Organization University of Tokyo
Division name Department of Radiology
Zip code
Address 7-3-1 Hongo Bunkyo-ku Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokyo
Division name Department of Radiology
Zip code
Address 7-3-1 Hongo Bunkyo-ku Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Radiology, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 08 Month 30 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
2010 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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 08 Month 26 Day
Last modified on
2014 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004691

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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