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

ID#: NCT04054310

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: August 05, 2020

End Date: December 30, 2021

Contact Information:
Velko Tonev, BSc.
01865655343
Andrea Dennis, PhD.
01865655343
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