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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028032
Receipt No. R000032097
Scientific Title Assessment of treatment area by transcatheter arterial chemoembolization under administration of SPIO using MRI
Date of disclosure of the study information 2017/09/01
Last modified on 2017/10/05

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Basic information
Public title Assessment of treatment area by transcatheter arterial chemoembolization under administration of SPIO using MRI
Acronym Assessment of treatment area by transcatheter arterial chemoembolization under administration of SPIO using MRI
Scientific Title Assessment of treatment area by transcatheter arterial chemoembolization under administration of SPIO using MRI
Scientific Title:Acronym Assessment of treatment area by transcatheter arterial chemoembolization under administration of SPIO using MRI
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to clarify a relationship between local recurrence of the hepatocellular carcinoma and treatment area by transcatheter arterial chemoembolization under administration of SPIO using MRI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes local recurrence
Key secondary outcomes

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
Device,equipment
Interventions/Control_1 MRI scan under administration of SPIO before transcatheter arterial chemoembolization.
MRI scan 3 to 5 days after the transcatheter arterial chemoembolization
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)Diagnosis of hepatocellular carcinoma according to EASL guideline
2)Chemoembolization is indicated.
3)Performance status of 0-2
4)Liver function of Child-pugh A or B
5)eGFR is 30mL/min/1.73m2 or more
6)Platelet count of 50,000 microL or more
7)No previous treatment or 4 weeks after the previous treatment
8)Informed consent is obtained.
Key exclusion criteria 1)Rupture of hepatocellular carcinoma
2)History of surgical or endoscopic treatment of bile duct
3)Prominent arterioportal or arteriovenous shunts
4)Dissection or stenosis of 50% or more in the celiac trunk or hepatic artery
5)Hepatic coma or severe psychiatric disorder
6)Severe drug allergy including SPIO or iodine contast allergy
7)Inadequate patients to undergo the procedure safely
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sodai Hoshiai
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Radiology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575 Japan
TEL 0298533205
Email hoshiai@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sodai Hoshiai
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Radiology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575 Japan
TEL 0298533205
Homepage URL
Email hoshiai@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 09 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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
2017 Year 07 Month 01 Day
Last modified on
2017 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032097

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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