Novel MRE Technique to Assess a Risk Factor for Liver Cancer

Not Recruiting

Trial ID: NCT05165446

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

Stanford Investigator(s)

Natalie Torok
Natalie Torok

Professor of Medicine (Gastroenterology and Hepatology)

Eligibility

Inclusion Criteria:

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. 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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Adrian Ekelmans
(650) 721-8436

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