Novel MRE Technique to Assess a Risk Factor for Liver Cancer

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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).

Official Title

Novel MRE Technique to Assess Tissue Viscoelasticity as a Risk Factor for Liver Cancer

Eligibility Criteria

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 1. Male or non-pregnant/non-lactating women ≥ 18 years of age 2. Diagnosis of NASH 3. Diagnosis of pre-cirrhotic fibrosis (F1-F3), diagnosed as per standard of care (history, exam, laboratory tests, Fibroscan, within 6 months of enrollment) 4. 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. 5. Groups both with and without T2DM will be enrolled. 6. Women of childbearing potential must agree to at least two methods of contraception. 7. Will not participate in any other clinical trial for the duration of the study 8. Will not consume alcohol for the duration of the study 9. 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. 10. Able to undergo 3 Tesla MRI and complete MRI screening form 11. Ability to understand and the willingness to sign a written informed consent document. 12. ECOG or Karnofsky Performance Status will be not be employed
Exclusion Criteria:
  1. 1. 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). 2. ALT>300 U/l 3. Total serum bilirubin ≥ to 1.3 mg/dL (Gilbert's Syndrome patients are excepted) 4. International Normalized Ratio (INR) ≥ 1.3 5. MELD>9 6. Serum creatinine >2.0mg/dl 7. Known alcohol abuse or alcohol use disorder (AUDIT profile and/or pos. urine ethylglucuronide): - >20 g/day for women - >30 g/day for men 8. Active substance abuse 9. Platelet count ≤100//mm3 10. Hemoglobin <11 g/dl in females or <12 g/dl in males 11. Presence/history of HCC, or other primary or metastatic cancer to the liver. 12. History of liver transplantation 13. History of bariatric surgery 14. History of inflammatory bowel disease 15. History of advanced pulmonary disease 16. Any concerns regarding compliance by enrolling physician 17. Pregnant or lactating women. 18. Presence of cardiac implantable electronic device (CIED) 19. History of CIED with retained leads 20. Presence of any metallic foreign body that is unsafe for the MRI environment 21. Inability to undergo MRI based on responses to the MRI screening form 22. History of claustrophobia or the need for sedation to undergo MRI


Natalie Torok
Natalie Torok
Hepatologist, Liver transplantation specialist
Professor of Medicine (Gastroenterology and Hepatology)

Contact us to find out if this trial is right for you.


Adrian Ekelmans
(650) 721-8436