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

Recruiting now · Not applicable

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT04054310

Run by

Perspectum

People needed

225

Starts

2020-08-05

Expected to finish

2026-06-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• RUSH University Medical Center — Chicago, Illinois, United States (enrolling)
• Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• Arizona Liver Health — Chandler, Arizona, United States (enrolling)
• Virginia Common wealth University — Richmond, Virginia, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Liver Center of Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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