Actively Recruiting
Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study
Led by Perspectum · Updated on 2026-05-19
225
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a non-invasive MRI-based biomarker called corrected T1 (cT1) to identify patients with suspected non-alcoholic steatohepatitis (NASH) who are referred for liver biopsy. The study focuses on distinguishing patients with a NASH activity score (NAS) of 4 or higher and fibrosis stage 2 or more, which are important markers for NASH severity and progression. This research addresses the challenge of reducing unnecessary biopsies by improving diagnostic accuracy using imaging techniques. Participants will undergo an MRI procedure called LiverMultiScan12, which produces cT1, T2*, and proton density fat fraction (PDFF) images of the liver. This single-arm study involves patients suspected of having non-alcoholic fatty liver disease (NAFLD) or NASH who are scheduled for routine liver biopsy as part of their medical care. The MRI scans aim to detect liver inflammation, fibrosis, and fat content to better predict histological findings. During the 12-month study, participants will have their diagnostic performance evaluated by comparing MRI results with liver biopsy findings. Researchers will assess how well cT1 and PDFF correlate with histopathological features and measure the accuracy of cT1 in identifying fibro-inflammatory liver disease. The study includes various clinical assessments and monitoring to support its primary and secondary outcome measures, ensuring comprehensive evaluation of liver health.
CONDITIONS
Brief 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 using a 16 gauge needle for percutaneous or 18 gauge needle for trans-jugular biopsy 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 (ALT60), BMI 65 kg/m2, hypertension, type II diabetes, dyslipidemia, low HDL (<40 mg/dl in men or <50 mg/dl in women), hypertriglyceridemia (6150 mg/dl), hypercholesterolemia (60200 mg/dl), or triglycerides/HDL >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 laparoscopic or wedge liver biopsy or biopsy 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, HCV, or HBV
- History or diagnosis of cirrhosis or hepatic decompensation including ascites, encephalopathy, or variceal bleeding
- Significant drug or alcohol abuse within 12 months of screening
- Contraindications or limitations to MRI scanning such as claustrophobia, pacemaker, metal implants, inability to lie flat or hold breath, or severe obesity
- Medical conditions with significant hypervolemia like congestive heart failure
- Weight reduction surgery within 3 years
- Other serious medical or psychiatric conditions considered 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo MRI scans to create cT1, T2* and PDFF images of their liver as part of diagnostic testing alongside routine liver biopsy.
1 baseline MRI visit and 1 liver biopsy visit as part of routine clinical care
Duration - Up to 12 months
Participants are followed to evaluate the diagnostic performance of cT1 and PDFF over time.
Follow-up visits as needed for monitoring outcomes
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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