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Diagnostic Test

Liver Multi Scan for Non-alcoholic Steatohepatitis

N/A
Recruiting
Led By Arun Sanyal, M.D.
Research Sponsored by Perspectum
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and Female subjects aged between 18 and 75 years old
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
Must not have
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
Inability to undergo a liver biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether CT1 can help distinguish patients with suspected NASH who have NAS≥4 & F≥2 from those without.

Who is the study for?
This trial is for adults aged 18-75 with suspected non-alcoholic fatty liver disease (NAFLD) who are scheduled for a liver biopsy and have risk factors like high body weight, diabetes, or abnormal blood fats. People with other chronic liver diseases, recent substance abuse, MRI contraindications like claustrophobia or metal implants, severe obesity, or certain medical conditions can't participate.
What is being tested?
The N-QUAN trial is testing the 'Liver Multi Scan' technology to see how well it identifies patients with significant levels of both fat and scarring in their livers compared to standard biopsies. It's focused on those suspected of having NAFLD/NASH.
What are the potential side effects?
Since the intervention involves a Liver Multi Scan which is an imaging technique similar to an MRI scan, there are generally no direct side effects from the scan itself. However, discomfort due to lying still during scanning may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am scheduled for a liver biopsy using a specific needle size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have a liver biopsy.
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I am scheduled for a specific liver biopsy procedure.
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I have had or am planning to have a liver transplant.
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I have been diagnosed with NASH through tissue examination.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic performance of cT1
Secondary study objectives
Correlation between cT1 and hisopathological features
Diagnostics performance of PDFF

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study-gateExperimental Treatment1 Intervention
Single arm of biopsy naïve participants suspected of having NAFLD or NASH, who have been referred for a liver biopsy as part of routine clinical care

Find a Location

Who is running the clinical trial?

PerspectumLead Sponsor
34 Previous Clinical Trials
13,370 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
1,644 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Arun Sanyal, M.D.Principal InvestigatorVCU School of Medicine
~43 spots leftby Nov 2025
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