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

Sponsored by Perspectum

About this study

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.

NASH trials will often use the criteria proposed by the NASH Clinical Research Network (NASH-CRN), the NAS scoring system, to classify patients as suitable for study enrolment. NAS is a summation of the histology scores for fat (0-3), inflammation (0-3), and ballooning (0-2) with a score of 4 or 5 or higher regarded as NASH. Whilst the score doesn't include fibrosis, the rapidly evolving clinical trials landscape in NASH has seen a shift in emphasis from drugs proposed to target liver fat to the targeting of fibrosis. This was due to observations contrary to the previously held belief that fibrosis could not improve, and the data to support fibrosis being predictive of clinical outcomes. As a result, many clinical trials now require patients to have a NAS ≥4 or 5, with the regulatory accep…

Where this study is enrolling (6)

Show all 6 locations
Who can participate

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

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Trial data sourced from ClinicalTrials.gov.