UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010887 |
|---|---|
| Receipt number | 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 16:18:03 |
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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
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
yasuimai@leto.eonet.ne.jp
Sponsor or person
Institute
Osaka Liver Study Group for Diagnosis,Treatment and Prevention of Hepatocellular Carcinoma
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009697
| Research Plan | |
|---|---|
| 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 |
