Active — Not RecruitingNot Applicable

Novel MRE Technique to Assess a Risk Factor for Liver Cancer

United States35 participantsStarted 2022-01-27

Plain-language 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).

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT05165446

SponsorNatalie Torok

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More NASH - Nonalcoholic Steatohepatitis trials