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 UMIN000025406
Receipt No. R000029169
Scientific Title Efficacy of the assessment of ablative margin after radiofrequency ablation for hepatocellular carcinoma using magnetic resonance imaging with superparamagnetic iron oxide (SPIO)
Date of disclosure of the study information 2016/12/26
Last modified on 2016/12/26

* 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 Efficacy of the assessment of ablative margin after radiofrequency ablation for hepatocellular carcinoma using magnetic resonance imaging with superparamagnetic iron oxide (SPIO)
Acronym Efficacy of the assessment of ablative margin after RFA for HCC using MRI with SPIO
Scientific Title Efficacy of the assessment of ablative margin after radiofrequency ablation for hepatocellular carcinoma using magnetic resonance imaging with superparamagnetic iron oxide (SPIO)
Scientific Title:Acronym Efficacy of the assessment of ablative margin after RFA for HCC using MRI with SPIO
Region
Japan

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

Objectives
Narrative objectives1 To clarify the relation between ablative margin and local tumor recurrence in RFA for HCC
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Local progression-free survival
Key secondary outcomes Child-Pugh grade 6 months after RFA

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 RFA is performed within 8hrs after SPIO-enhanced MRI.
The ablative margin is evaluated with contrast-enhanced CT and non-enhanced MRI after 3days or later from RFA.
Child-Pugh score of the patient is calculated 6m after RFA.
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 Hypervascular HCC (=< 3cm and =< 3 nodules)
Detectable HCC by ultrasonography
Capable of undergoing contrast-enhanced CT
Capable of undergoing SPIO-enhanced MRI
Child-Pugh grade: A or B
Key exclusion criteria Massive ascites
Undetectable HCC by SPIO-enhanced MRI
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensaku Mori
Organization University of Tsukuba
Division name Radiology
Zip code
Address Tennodai 1-1-1, Tsukuba, Ibaraki, Japan.
TEL +81-29-853-3205
Email moriken@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuniaki Fukuda
Organization University of Tsukuba
Division name Gastroenterology
Zip code
Address Tennodai 1-1-1, Tsukuba, Ibaraki, Japan.
TEL +81-29-853-3218
Homepage URL
Email k-fukuda@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization none
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
2016 Year 12 Month 26 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 Completed
Date of protocol fixation
2007 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 26 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.