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N-QUAN Study for Liver Health in NASH

This study, called N-QUAN, is looking for a new way to check liver health in people with NASH (Nonalcoholic Steatohepatitis). It's testing a special type of MRI called Liver Multi Scan. This MRI creates detailed images of your liver (cT1, T2*, and PDFF images) to see how well it can tell the difference between people with more severe NASH (a score of NAS≥4 and F≥2) and those with less severe NASH. You might be able to join if you are between 18 and 75 years old, understand and sign consent forms, and are already scheduled for a liver biopsy. The study aims to see how well the cT1 measurement from the MRI works after 12 months.

Study design
This is an interventional study with a planned enrollment of 225 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo a Liver Multi Scan MRI. You must also be scheduled for a standard diagnostic liver biopsy (percutaneous or trans-jugular).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 months, suggesting follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04054310

Non-Invasive Quantification of Liver Health in NASH (N-QUAN)

Recruiting
NAAges 18–75InterventionalDiagnostic
Perspectum
~225 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Liver Multi Scan

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic performance of cT1
Measured over 12 months

Conditions

NASH - Nonalcoholic Steatohepatitis

Explore related trials

Nonalcoholic Steatohepatitis

NCT04054310

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arizona Liver Health

    Chandler, Arizonastudy coordinator listed

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Indiana University Health

    Indianapolis, Indianastudy coordinator listed

    Recruiting

  • RUSH University Medical Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • University of Virginia

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

  • Virginia Common wealth University

    Richmond, Virginiastudy coordinator listed

    Recruiting

  • Liver Center of Texas

    Dallas, Texasno site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Arun Sanyal, M.D. · PRINCIPAL_INVESTIGATOR · VCU School of Medicine

Who to contact

Cayden Beyer
[email protected]
01865655343
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Diagnostic performance of cT112 months

    To evaluate, in patients with suspected Nash referred for Liver biopsy, the diagnostic performance of cT1 at discriminating those patients with NAS≥4 \& F≥2 from those patients without. In order to evaluate the diagnostic performance area under the receiver operative curve (AUROC) will be analysised.