Novel MRE Technique to Assess a Risk Factor for Liver Cancer

Other illness

• 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).
• Known alcohol abuse or alcohol use disorder (AUDIT profile and/or pos. urine ethylglucuronide):
  • \>20 g/day for women
  • \>30 g/day for men
• 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
• Presence of cardiac implantable electronic device (CIED)
• History of CIED with retained leads
• History of claustrophobia or the need for sedation to undergo MRI

Lab values

• ALT\>300 U/l
• Total serum bilirubin ≥ to 1.3 mg/dL (Gilbert's Syndrome patients are excepted)
• International Normalized Ratio (INR) ≥ 1.3
• Serum creatinine \>2.0mg/dl
• Platelet count ≤100//mm3
• Hemoglobin \<11 g/dl in females or \<12 g/dl in males

Other

• MELD\>9
• Active substance abuse
• Any concerns regarding compliance by enrolling physician
• Pregnant or lactating women.
• 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

• 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