UMIN ID: UMIN000000788
Registered date:01/04/2012
A clinical trial of liver SPIO-MRI in the diagnosis of nonalcoholic steatohepatitis
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Nonalcoholic steatohepatitis |
| Date of first enrollment | 2006/01/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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. |
Outcome(s)
| Primary Outcome | Liver imaging in SPIO-MRI |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Division of Gastroenterolgy and Hepatology, Department of Internal Medicine, Keio University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kengo Tomita |
| Address | 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan Japan |
| Telephone | 03-3353-1211(ext62384) |
| kengo@boreas.dti.ne.jp | |
| Affiliation | Department of Internal Medicine, Keio University School of Medicine Division of Gastroenterolgy and Hepatology |
| scientific contact | |
| Name | Kengo Tomita |
| Address | 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan Japan |
| Telephone | 03-3353-1211(ext62384) |
| Affiliation | Department of Internal Medicine, Keio University School of Medicine Division of Gastroenterology and Hepatology |