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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38820

Enrollment

Registered

2013-10-28

Start date

2014-02-04

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lever aandoening, steatose en non-alcoholische steatohepatitis fatty liver disease hepatitis Non-alcoholic steatoheptitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 20 g/day. Viral hepatitis. Planned diagnostic MRI scan in the next 6 months.

Design outcomes

Primary

Measure	Time frame
The main endpoint of this study is mean change in T2 and T2* at in the liver directly after the administration of Rienso.	—

Countries

Netherlands

Outcome results