Non-Invasive Quantification of Liver Health in NASH (N-QUAN)

NCT04054310 | Recruiting FDA Device

• 1 other identifier: IIP137
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 7

Brief Summary

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

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of cT1

  To evaluate, in patients with suspected Nash referred for Liver biopsy, the diagnostic performance of cT1 at discriminating those patients with NAS≥4 \& F≥2 from those patients without. In order to evaluate the diagnostic performance area under the receiver operative curve (AUROC) will be analysised.

  12 months

Secondary Outcomes (2)

• Diagnostics performance of PDFF

  12 months

• Correlation between cT1 and hisopathological features

  12 months

Study Arms (1)

Study-gate

EXPERIMENTAL

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

Diagnostic Test: Liver Multi Scan

Interventions

Liver Multi Scan DIAGNOSTIC_TEST

MRI to create cT1, T2\* and PDFF images of patients liver.

Also known as: Biopsy

Study-gate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Perspectum: lead

Study Sites (7)

Arizona Liver Health

Chandler, Arizona, 85224, United States

RECRUITING

RUSH University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Indiana University Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Liver Center of Texas

Dallas, Texas, 75234, United States

ACTIVE NOT RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Virginia Common wealth University

Richmond, Virginia, 23284, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Arun Sanyal, M.D.

  VCU School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cayden Beyer

CONTACT

01865655343; cayden.beyer@perspectum.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 13, 2019
• Study Start: August 5, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)