*The use of 18F-fluorodeoxyglucose positron emission tomography and computed tomography imaging for the detection of inflammation in steatotic livers as an indicator of non-alcoholic steatohepatitis*

Recruiting

• Conditions: fatty liver; hepatic steatohepatitis; 10019654; 10018424

• Registration Number: NL-OMON32768
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

* Men and women * 18 yrs of age
* Fasting plasma glucose *7.0 mmol/l
* Liver biopsy in the last 6 months prior to inclusion or existing medical indication indication for liver biopsy
* Written informed consent

Exclusion Criteria

* Exclusion criteria for MR (claustrophobia, pacemaker, metal implants, etc)
* Exclusion criteria for liver biopsy (bleeding tendency, extended bile ducts etc)
* ALT levels * 150 IU/ml
* Creatinine levels * 120 IU/ml
* Present excessive alcohol use defined as > 2 units/day
* Present abuse of i.v. drugs (including methadon)
* Infection with HIV or Hepatitis B/C
* A psychiatric, addictive or any disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is the level of hepatic FDG uptake in<br /><br>non-diabetic patients with biopsy-proven NASH and the level of hepatic<br /><br>FDG-uptake in non-diabetic patients with biopsy-proven non-inflammatory<br /><br>steatosis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>FDG uptake levels will be studied in correlation with hepatic lipid content<br /><br>measured by 1H-MR-S, glucose tolerance status, determined by OGTT,<br /><br>transaminases and biochemical markers of inflammation. </p><br>