Non-Invasive Assessment of Liver Health in Patients with NASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a non-invasive imaging technique called Liver Multi Scan in diagnosing patients with suspected Nonalcoholic Steatohepatitis (NASH) who are scheduled for a liver biopsy. It aims to differentiate patients with a specific histological score indicative of NASH from those without. The study focuses on patients presenting with risk factors for NASH, such as elevated liver enzymes and metabolic syndrome. By utilizing advanced imaging, the study seeks to improve diagnostic accuracy and reduce the need for invasive procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Arizona Liver Health
  Chandler, Arizona, United States Recruiting
• RUSH University Medical Center
  Chicago, Illinois, United States Recruiting
• Indiana University Health
  Indianapolis, Indiana, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• University of Virginia
  Charlottesville, Virginia, United States Recruiting
• Virginia Common wealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Arun Sanyal, M.D. — VCU School of Medicine
• Study coordinator: Cayden Beyer
• Email: cayden.beyer@perspectum.com
• Phone: 01865655343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Multiple under-the-skin injections of B1344 for adults with NAFLD and NASH

  This trial will test whether repeated subcutaneous injections of an experimental drug called B1344 are safe and affect liver fat and related measures in adults with NAFLD or NASH.

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• Evaluating bariatric surgery for treating severe liver disease in obese patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.