Novel MRE Technique to Assess a Risk Factor for Liver Cancer

NCT05165446 | Active Not Recruiting

• 1 other identifier: 62249
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

Fatty Liver; NAFLD; Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• Novel MRE technique to assess tissue viscoelasticity as a risk factor for liver cancer

  Safety:MRE evaluation of the liver for stiffness is a standard of care test. We do not expect issues as this is a non-invasive technique. Our MR may require a longer session compared to the traditional MRE (40 minutes of scan time for multifrequency MRE, as compared to 25 minutes for conventional MRE). However, all issues, patient symptoms will be recorded. Technical Feasibility: The MRE algorithm we will use has previously been shown to produce data from a different scanner platform, across all frequencies. Feasibility of multifrequency MRE will be assessed by descriptive summary of technical success and image quality for each of the individual reconstructed MRE datasets (stiffness, elasticity, and viscosity). Mean and standard deviation for the MRE outcome variables viscosity elasticity and stiffness will be presented and tested for the difference in means between the 2 groups by way of ANOVA, and if a difference is found, followed by Tukey's test.

  For individual patients: duration of the study 8 weeks (including lab, scheduling the MR and 4w post MR period).

Secondary Outcomes (1)

• Studies on liver injury and glycemic control.

  For individual patients: duration of the study 8 weeks

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include one group of healthy subjects and two groups with 15 patients each which will enroll in parallel, one group with type 2 diabetes mellitus (T2DM), and one group without DM.

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

Sponsors & Collaborators

• Natalie Torok: lead

Study Sites (1)

Stanford Hospital

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1 tablespoon (13 mL) blood

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalie Torok, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: January 27, 2022
• Primary Completion: January 1, 2024
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)