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Recruiting Not applicable

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

NCT04054310 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Not applicable
Started
2020-08-05
Last updated
2026-05-19

Condition(s) studied

NASH - Nonalcoholic Steatohepatitis

Investigational drug(s) / intervention(s)

Liver Multi Scan

Liver Multi Scan: MRI to create cT1, T2\* and PDFF images of patients liver.

Study summary

To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \& F≥2 from those without.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Diagnostic performance of cT1 — 12 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.

Trial sites (7)

FacilityCityRegionStatus
Arizona Liver Health Chandler Arizona Recruiting
RUSH University Medical Center Chicago Illinois Recruiting
Indiana University Health Indianapolis Indiana Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Liver Center of Texas Dallas Texas Active Not Recruiting
University of Virginia Charlottesville Virginia Recruiting
Virginia Common wealth University Richmond Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04054310 on ClinicalTrials.gov ↗ ← All trials in the USA