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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000788
Receipt No. R000000945
Scientific Title A clinical trial of liver SPIO-MRI in the diagnosis of nonalcoholic steatohepatitis
Date of disclosure of the study information 2012/04/01
Last modified on 2007/08/04

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Basic information
Public title A clinical trial of liver SPIO-MRI in the diagnosis of nonalcoholic steatohepatitis
Acronym Liver SPIO-MRI in NASH
Scientific Title A clinical trial of liver SPIO-MRI in the diagnosis of nonalcoholic steatohepatitis
Scientific Title:Acronym Liver SPIO-MRI in NASH
Region
Japan

Condition
Condition Nonalcoholic steatohepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the safety and efficacy of magnetic resonance imaging using superparamagnetic iron oxide particles (SPIO-MRI) in the diagnosis of nonalcoholic steatohepatitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Liver imaging in SPIO-MRI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Duration: three years
Patients, who will undergo liver biopsy for clinical suspicion of nonalcoholic steatohepatitis (NASH), will be enrolled in this study. The patients will take liver SPIO-MRI examination at the time of liver biopsy. The aim of this study is to identify the liver SPIO-MRI findings in patients with biopsy-proven "NASH" and "not NASH", and to assess their correlations with the clinicopathological variables.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The patients, who will undergo liver biopsy for clinical suspicion of nonalcoholic steatohepatitis, and from whom we can obtain informed consents.
Key exclusion criteria The patients who have no normal judgement ability for infomed consent.
The patients who have past history of allergy to Resovist, contrast agent for liver SPIO-MRI, or kind medicine.
The patients who are pregnant or will doublfully be pregnant.
The patients who the treating doctors decide are inadequate to enrollment to this trial.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Tomita
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211(ext62384)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Tomita
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Gastroenterolgy and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211(ext62384)
Homepage URL http://web.sc.itc.keio.ac.jp/medicine/nash_nafld/index.html
Email kengo@boreas.dti.ne.jp

Sponsor
Institute Division of Gastroenterolgy and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 04 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
Date of protocol fixation
2005 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2009 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 08 Month 04 Day
Last modified on
2007 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000945

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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