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*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*

*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* - The FLAME study: FDG detection of inflammation in steatosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32768
Enrollment
16
Registered
2008-08-08
Start date
2009-01-09
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

fatty liver hepatic steatohepatitis

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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: * 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

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is the level of hepatic FDG uptake in non-diabetic patients with biopsy-proven NASH and the level of hepatic FDG-uptake in non-diabetic patients with biopsy-proven non-inflammatory steatosis

Secondary

MeasureTime frame
FDG uptake levels will be studied in correlation with hepatic lipid content measured by 1H-MR-S, glucose tolerance status, determined by OGTT, transaminases and biochemical markers of inflammation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)