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RECRUITINGINTERVENTIONAL

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

Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Male and Female subjects aged between 18 and 75 years old - Ability to understand and sign a written willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Liver Multi Scan

MRI to create cT1, T2\* and PDFF images of patients liver.

Locations (7)

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