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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010887
Receipt No. R000009697
Scientific Title Post-RFA Early Detection of HCC by Gd-EOB-DTPA-MRI study
Date of disclosure of the study information 2013/06/05
Last modified on 2018/09/06

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Basic information
Public title Post-RFA Early Detection of HCC by Gd-EOB-DTPA-MRI study
Acronym POSTER Study
Scientific Title Post-RFA Early Detection of HCC by Gd-EOB-DTPA-MRI study
Scientific Title:Acronym POSTER Study
Region
Japan

Condition
Condition Hepatocellular carcinoma (HCC)
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to compare detection sensitivity of recurrence of HCC after RFA between dynamic CT and GD-EOB-DTPA-enhanced MRI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection sensitivity of recurrence of hypervascular hepatocellular carcinoma after RFA between dynamic CT and GD-EOB-DTPA-enhanced MRI
Key secondary outcomes Number of tumors of recurrence of hepatocellular carcinoma after RFA between dynamic CT and GD-EOB-DTPA-enhanced MRI

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
Device,equipment
Interventions/Control_1 EOB-enhanced MRI/enhanced MDCT
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 1.Hypervascular HCC diagnosed on the basis of one of the following criteria and treated by radiofequency ablation within one month after diagnosis of HCC.
*Definition of hypervascular HCC
a)Early stain on arterial phase and washout on late phase of dynamic CT or Gd-EOB-DTPA-enhanced MRI.
b)Early stain on arterial phase, washout on late phase and hyperintensity on hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI.
When hypovascular tumor more than 1.5cm in diameter is present, it should be diagnosed by liver biopsy and be treated in case of HCC.
2. =>20 years old at the time of entry
3.Body weight <100kg
4.Any cause of underlying liver disease
Key exclusion criteria 1.Extrahepatic liver metastasis
2.History of any cancer other than HCC within 5 years
3.Contraindication for MRI
4.Hypersensitivity to contrast agents of MRI or CT
5.Cirrhosis of Child-Pugh grade C
6.Hepatic encephalopathy of more than grade 2
7.Serum total bilirubin level of => 3 mg/dl
8.Patients judged as unsuitable for this study by the investiagators
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuharu Imai
Organization Ikeda Municipal Hospital
Division name Department of Gastroenterology
Zip code
Address 3-1-18 Jonan,Ikeda-city,Osaka
TEL 072-751-2881
Email yasuimai@leto.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuharu Imai
Organization Ikeda Municipal Hospital
Division name Department of Gastroenterology
Zip code
Address -1-18 Jonan,Ikeda-city,Osaka
TEL 072-751-2881
Homepage URL
Email yasuimai@leto.eonet.ne.jp

Sponsor
Institute Osaka Liver Study Group for Diagnosis,Treatment and Prevention of Hepatocellular Carcinoma
Institute
Department

Funding Source
Organization SCCRE
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
2013 Year 06 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 05 Day
Last modified on
2018 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009697

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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