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

Launched by PERSPECTUM · Aug 12, 2019

Keywords

ClinConnect Summary

The N-QUAN trial is studying how well a non-invasive test, called CT1, can help identify patients with a liver condition known as Nonalcoholic Steatohepatitis (NASH). This trial is specifically for adults aged 18 to 75 who are suspected of having NASH and are scheduled to have a liver biopsy. To be eligible, participants should have certain risk factors, such as elevated liver enzymes, being overweight, or having conditions like high blood pressure or type 2 diabetes.

Participants in the trial can expect to undergo the CT1 test, which aims to provide information about their liver health without needing more invasive procedures. It’s important for potential participants to know that individuals with a prior diagnosis of NASH or certain other liver diseases won’t be eligible for this study. The trial is currently recruiting, and it offers an opportunity to help improve the understanding of liver health in patients with NASH.

Gender

ALL

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