Active — Not RecruitingNot Applicable

Novel MRE Technique to Assess a Risk Factor for Liver Cancer

United States35 participantsStarted 2022-01-27

Plain-language summary

The aim of this proposal is to investigate a novel imaging method to identify patients with non-alcoholic steatohepatitis (NASH) who are at risk for hepatocellular carcinoma (HCC).

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Male or non-pregnant/non-lactating women ≥ 18 years of age
✓. Diagnosis of NASH
✓. Diagnosis of pre-cirrhotic fibrosis (F1-F3), diagnosed as per standard of care (history, exam, laboratory tests, Fibroscan, within 6 months of enrollment)
✓. Na-MELD \< 9: The Na-MELD (sodium-Model for End Stage Liver Disease) score is routinely used to assess liver synthetic function and life expectancy. Patients with Na-MELD\<9 have less than 1.9% 3 months liver-related mortality risk, and their liver synthetic function is normal.
✓. Groups both with and without T2DM will be enrolled.
✓. Women of childbearing potential must agree to at least two methods of contraception.
✓. Will not participate in any other clinical trial for the duration of the study
✓. Will not consume alcohol for the duration of the study

Exclusion criteria

✕. Presence of any other form of liver disease, including viral hepatitis, autoimmune hepatitis, alcoholic liver disease, genetic causes of chronic liver disease, cardiogenic liver disease, and HIV positivity (can cause liver fibrosis).
✕. ALT\>300 U/l
✕. Total serum bilirubin ≥ to 1.3 mg/dL (Gilbert's Syndrome patients are excepted)
✕. International Normalized Ratio (INR) ≥ 1.3
✕. MELD\>9
✕. Serum creatinine \>2.0mg/dl
✕. Known alcohol abuse or alcohol use disorder (AUDIT profile and/or pos. urine ethylglucuronide):
✕. Active substance abuse

What they're measuring

Novel MRE technique to assess tissue viscoelasticity as a risk factor for liver cancer

Timeframe: For individual patients: duration of the study 8 weeks (including lab, scheduling the MR and 4w post MR period).

Trial details

NCT IDNCT05165446

SponsorNatalie Torok

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More NASH - Nonalcoholic Steatohepatitis trials