UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of the assessment of ablative margin after radiofrequency ablation for hepatocellular carcinoma using magnetic resonance imaging with superparamagnetic iron oxide (SPIO)
Title of the study (Brief title)	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	Kensaku Mori
Organization	University of Tsukuba
Division name	Radiology
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	Kuniaki Fukuda
Organization	University of Tsukuba
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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