UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000788 |
|---|---|
| Receipt number | 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 | 2025/02/15 15:15:03 |
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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)
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
kengo@boreas.dti.ne.jp
Sponsor or person
Institute
Division of Gastroenterolgy and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2005 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2005 | Year | 12 | Month | 01 | Day |
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
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000945
