Novel MRE Technique to Assess a Risk Factor for Liver Cancer

Running, not enrolling

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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).

Key facts

Study ID

NCT05165446

Run by

Natalie Torok

People needed

35

Starts

2022-01-27

Expected to finish

2026-08-30

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• If on vitamin E, pioglitazone or any anti diabetic treatment prior to the study, will have been on stable therapies for 6 months prior to enrolment.
• Able to undergo 3 Tesla MRI and complete MRI screening form
• Ability to understand and the willingness to sign a written informed consent document.
• ECOG or Karnofsky Performance Status will be not be employed

You may not qualify if…

• 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):
• >20 g/day for women
• >30 g/day for men
• Active substance abuse
• Platelet count ≤100//mm3
• Hemoglobin <11 g/dl in females or <12 g/dl in males
• Presence/history of HCC, or other primary or metastatic cancer to the liver.
• History of liver transplantation
• History of bariatric surgery
• History of inflammatory bowel disease
• History of advanced pulmonary disease
• Any concerns regarding compliance by enrolling physician
• Pregnant or lactating women.
• Presence of cardiac implantable electronic device (CIED)
• History of CIED with retained leads
• Presence of any metallic foreign body that is unsafe for the MRI environment
• Inability to undergo MRI based on responses to the MRI screening form
• History of claustrophobia or the need for sedation to undergo MRI

Where it is running

• Stanford Hospital — Stanford, California, United States

Full record on ClinicalTrials.gov

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