Actively Recruiting
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
Led by Perspectum · Updated on 2025-12-01
225
Participants Needed
7
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and Female subjects aged between 18 and 75 years old
- Ability to understand and sign a written informed consent form
- Patients scheduled to undergo a standard of care diagnostic liver biopsy, either percutaneous with a 16 gauge needle or trans-jugular with an 18 gauge needle into the right lobe
- Patients suspected of having NAFLD considered for treatment and presenting with two or more of the following risk factors: elevated liver enzymes (ALT ≥40), BMI ≥25 kg/m², hypertension, type II diabetes, dyslipidemia, low HDL (<40 mg/dl in men or <50 mg/dl in women), hypertriglyceridemia (≥150 mg/dl), hypercholesterolemia (≥200 mg/dl), or triglycerides/HDL ratio >5.0
You will not qualify if you...
- Prior histopathological diagnosis of NASH
- Inability to undergo a liver biopsy
- Prior or planned liver transplantation
- Scheduled for laparoscopic or wedge liver biopsy or biopsy taken from the left lobe
- Participation in an investigational new drug trial within 30 days before enrollment
- Other known causes of chronic liver disease such as alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, iron overload, alpha-1 antitrypsin deficiency, hepatitis C or B virus
- History or diagnosis of cirrhosis or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding
- Clinically relevant drug or alcohol abuse within 12 months before screening
- Contraindications or significant limitations to MRI scanning including claustrophobia, implanted devices like pacemakers, metal in body causing artifacts, inability to lie flat or hold breath during imaging
- Medical conditions likely to cause significant fluid overload such as congestive heart failure
- Severe obesity complicating MRI positioning
- Weight reduction surgery within 3 years
- Other significant medical illnesses or psychiatric conditions deemed high risk for study participation
- Failure to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Arizona Liver Health
Chandler, Arizona, United States, 85224
Actively Recruiting
2
RUSH University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
3
Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
5
Liver Center of Texas
Dallas, Texas, United States, 75234
Active, Not Recruiting
6
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
7
Virginia Common wealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
Research Team
C
Cayden Beyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here