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

Description

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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Study Overview

Study Details

Study overview

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.

Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study

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

Condition
NASH - Nonalcoholic Steatohepatitis
Intervention / Treatment

-

Contacts and Locations

Chandler

Arizona Liver Health, Chandler, Arizona, United States, 85224

Chicago

RUSH University Medical Center, Chicago, Illinois, United States, 60612

Indianapolis

Indiana University Health, Indianapolis, Indiana, United States, 46202

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Dallas

Liver Center of Texas, Dallas, Texas, United States, 75234

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

Richmond

Virginia Common wealth University, Richmond, Virginia, United States, 23284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Perspectum,

Arun Sanyal, M.D., PRINCIPAL_INVESTIGATOR, VCU School of Medicine

Study Record Dates

2024-05-01