Non-Invasive Assessment of Liver Health in Patients with NASH
Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study
This study is testing a new imaging method to see if it can accurately identify patients with Nonalcoholic Steatohepatitis (NASH) without needing a liver biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Perspectum Industry-sponsored |
| Locations | 7 sites (Chandler, Arizona and 6 other locations) |
| Trial ID | NCT04054310 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are suspected of having NASH and are scheduled for a liver biopsy due to presenting risk factors.
Not a fit: Patients with a prior diagnosis of NASH or those unable to undergo a liver biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more accurate method for diagnosing NASH, potentially leading to earlier and more effective treatment options for patients.
How similar studies have performed: Other studies have shown promising results with non-invasive imaging techniques for liver assessment, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chandler, Arizona and 6 other locations
- 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)
- Liver Center of Texas — Dallas, Texas, United States (Active_not_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.