ltrasmall superparamagnetic particels of iron oxide (USPIO) enhanced MRI to differentiate between simple steatosis and non-alcoholic steatohepatitis.

Completed

• Conditions: ever aandoening, steatose en non-alcoholische steatohepatitis; fatty liver disease; hepatitis; Non-alcoholic steatoheptitis

• Registration Number: NL-OMON38820
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients who will have a liver biopsy on clinical grounds for suspicion of NASH as judged by their treating hepatologist.

Exclusion Criteria

History of anaphylaxis or other hypersensitivity reactions. Systemic inflammatory diseases. History of iron overload. History of renal failure or decreased renal function (eGFR <60 ml/min). Claustrophobia Metal-containing material in the body or attached to the body. Alcohol consumption > 20 g/day. Viral hepatitis. Planned diagnostic MRI scan in the next 6 months.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is mean change in T2 and T2* at in the liver<br /><br>directly after the administration of Rienso.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>