RecruitingNot ApplicableNCT04054310

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

Sponsor

Perspectum

Enrollment

225 participants

Start Date

Aug 5, 2020

Study Type

INTERVENTIONAL

Conditions

NASH - Nonalcoholic Steatohepatitis

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria15

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 Criteria26

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