Novel MRE Technique to Assess a Risk Factor for Liver Cancer
Trial ID or NCT#
Status
Purpose
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
- 1. Male or non-pregnant/non-lactating women ≥ 18 years of age2. Diagnosis of NASH3. 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 study8. Will not consume alcohol for the duration of the study9. 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 form11. Ability to understand and the willingness to sign a written informed consent document.12. ECOG or Karnofsky Performance Status will be not be employed
- 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/l3. Total serum bilirubin ≥ to 1.3 mg/dL (Gilbert's Syndrome patients are excepted)4. International Normalized Ratio (INR) ≥ 1.35. MELD\>96. Serum creatinine \>2.0mg/dl7. Known alcohol abuse or alcohol use disorder (AUDIT profile and/or pos. urine ethylglucuronide):
- * \>20 g/day for women * \>30 g/day for men8. Active substance abuse9. Platelet count ≤100//mm310. Hemoglobin \<11 g/dl in females or \<12 g/dl in males11. Presence/history of HCC, or other primary or metastatic cancer to the liver.12. History of liver transplantation13. History of bariatric surgery14. History of inflammatory bowel disease15. History of advanced pulmonary disease16. Any concerns regarding compliance by enrolling physician17. Pregnant or lactating women.18. Presence of cardiac implantable electronic device (CIED)19. History of CIED with retained leads20. Presence of any metallic foreign body that is unsafe for the MRI environment21. Inability to undergo MRI based on responses to the MRI screening form22. History of claustrophobia or the need for sedation to undergo MRI
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Adrian Ekelmans
(650) 721-8436
View on ClinicalTrials.gov