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Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
Recruiting
Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Liver Multi Scan (diagnostic test)
Sponsor: Perspectum · Participants: 225 · Started: Aug 5, 2020
Contact the study team
- Cayden Beyer · Phone: 01865655343
Official record on ClinicalTrials.gov — NCT04054310
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.