NASH - Nonalcoholic SteatohepatitisNCT05165446
Novel MRE Technique to Assess a Risk Factor for Liver Cancer
An observational study of NASH - Nonalcoholic Steatohepatitis, run by Natalie Torok at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2022to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
- History of inflammatory bowel disease
- History of advanced pulmonary disease
- Any concerns regarding compliance by enrolling physician
- Pregnant or lactating women.
- Presence of cardiac implantable electronic device (CIED)
- History of CIED with retained leads
- Presence of any metallic foreign body that is unsafe for the MRI environment
- Inability to undergo MRI based on responses to the MRI screening form
- History of claustrophobia or the need for sedation to undergo MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel MRE Technique to Assess Tissue Viscoelasticity as a Risk Factor for Liver Cancer
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).
Read the detailed description
NASH is the most common cause of chronic liver disease, and it is estimated that 40-50% of patients with obesity and T2DM have NASH. NASH can lead to HCC with the risk increasing 2-3 fold in patient with poor glycemic control. Unless caught early, HCC has a poor prognosis with no effective therapies. A unique feature of HCC in NASH is that it often arises at a pre-cirrhotic stage, and the prognosis is often dismal. There are no current surveillance strategies for these pre-cirrhotic patients. Based on our animal models and pilot patient studies, we developed a novel paradigm that linked liver matrix changes to a more aggressive HCC phenotype. Our goal is to develop an imaging-based surveillance tool that will identify early matrix changes that may predispose to HCC.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- Fatty Liver, NAFLD, Liver Fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
assess correlation to liver injury (AST, ALT) assess correlation to glycemic control HbA1c
Measured: For individual patients: duration of the study 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start27 Jan 2022
- Primary completion1 Jan 2024
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natalie Torok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Natalie Torok, Stanford University
- Investigators
- Natalie Torok, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165446
- Sponsor's protocol ID
- 62249
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel MRE Technique to Assess Tissue Viscoelasticity as a Risk Factor for Liver Cancer
- ClinicalTrials.gov ID
- NCT05165446
- Acronym / sponsor ID
- 62249
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- Fatty Liver, NAFLD, Liver Fibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Natalie TorokUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
NASH is the most common cause of chronic liver disease, and it is estimated that 40-50% of patients with obesity and T2DM have NASH. NASH can lead to HCC with the risk increasing 2-3 fold in patient with poor glycemic control. Unless caught early, HCC has a poor prognosis with no effective therapies. A unique feature of HCC in NASH is that it often arises at a pre-cirrhotic stage, and the prognosis is often dismal. There are no current surveillance strategies for these pre-cirrhotic patients. Based on our animal models and pilot patient studies, we developed a novel paradigm that linked liver matrix changes to a more aggressive HCC phenotype. Our goal is to develop an imaging-based surveillance tool that will identify early matrix changes that may predispose to HCC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Novel MRE technique to assess tissue viscoelasticity as a risk factor for liver cancer
Time frame: For individual patients: duration of the study 8 weeks (including lab, scheduling the MR and 4w post MR period).
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.
1 secondary outcome
Studies on liver injury and glycemic control.
Time frame: For individual patients: duration of the study 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Torok, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NASH - Nonalcoholic Steatohepatitis, run by Natalie Torok at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Novel MRE technique to assess tissue viscoelasticity as a risk factor for liver cancer (time frame: For individual patients: duration of the study 8 weeks (including lab, scheduling the MR and 4w post MR period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.