New MRI scan could spare NASH patients painful liver biopsies
NCT ID NCT04054310
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new, non-invasive MRI scan (called cT1) to see if it can accurately diagnose NASH, a serious liver disease. Currently, doctors need to take a small sample of liver tissue with a needle (biopsy) to confirm the diagnosis. The study will compare the MRI results with biopsy results in 225 adults who are already scheduled for a biopsy. If the scan works well, it could replace the need for many painful biopsies in the future.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 225 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male and Female subjects aged between 18 and 75 years old * Ability to understand and sign a written informed consent forms * Patients scheduled to undergo a standard of care diagnostic liver biopsy as follows * Percutaneous biopsy with a 16 gauged needle passed into the right lobe * Trans-jugular biopsy with an 18 gauged needle passed into the right lobe * Patients who are suspected of having NAFLD, who are being considered for treatment, and presenting with two or more of the following risk factors for NASH * Elevated liver enzymes (ALT≥40) * BMI≥25kG/m\^2 * Hypertension * Type II diabetes * Dyslipidameia * Low High-density lipoprotein (HDL) (\<40mg/dl in men or \<50mg/dl in women) * Hypertriglyceridemia (≥150mg/dl) * Hypercholestrolemia (≥200mg/dl) * Triglycerides (TG)/HDL\>5.0 Exclusion Criteria: * Prior histopathological diagnosis of NASH * Inability to undergo a liver biopsy * Prior or planned liver transplantation * Patient scheduled to undergo a laparoscopic or wedge liver biopsy or biopsy taken from the left lobe * Participation in an investigational new drug (IND) trial in the 30 days before enrolment * Other known causes of chronic liver disease based on clinical criteria at the study site such as the following: * Alcoholic liver disease * Primary biliary cirrhosis * Primary sclerosing cholangitis * Autoimmune Hepatitis * Wilson's disease, hemochromatosis, iron overload * Alpha/1/Antitrypsin (A1AT) deficiency * HCV, HBV * History or diagnosis of cirrhosis and or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding * Clinically relevant drug or alcohol abuse within 12 months of screening * Any contradiction or significant limitation to MRI scanning * Claustrophobia preventing MR imaging (requires 15-30 minutes in scanning) * Pacemaker or another implanted device * Metal in body (such as an aneurysm clip) that might produce artefacts on abdominal MRI or might be adversely impacted by a high magnetic field * Inability to lie flat, remain still or briefly hold breath as necessary during MR imaging * Medical condition likely to produce significant hypervolemia like congestive heart failure * Severe obesity complicating positioning in MR scanner * Weight reduction surgery within 3 years * Concomitant medical illnesses per investigators discretion (such as HIV infection, recent major surgery, uncontrolled heart disease, concurrent infection or fever of unknown origin, illicit drug use, cancer * Clinically significant medical or psychiatric condition considered a high risk participation in an investigational study * Failure to give informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Arizona Liver Health
RECRUITINGChandler, Arizona, 85224, United States
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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Indiana University Health
RECRUITINGIndianapolis, Indiana, 46202, United States
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Liver Center of Texas
ACTIVE_NOT_RECRUITINGDallas, Texas, 75234, United States
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RUSH University Medical Center
RECRUITINGChicago, Illinois, 60612, United States
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University of Virginia
RECRUITINGCharlottesville, Virginia, 22908, United States
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Virginia Common wealth University
RECRUITINGRichmond, Virginia, 23284, United States
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- Experimental drug aims to reverse liver scarring in NASH cirrhosis
- New drug HPG1860 shows promise in reducing liver fat in NASH patients
- Hope for NASH: new pill aims to reverse liver damage and prevent cirrhosis