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

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

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

Conditions2

Locations7 sites

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