Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
Trial Parameters
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Brief 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 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 laparoscop