Recruiting

N-QUAN

Sponsor:

Perspectum

Code:

NCT04054310

Conditions

NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Liver Multi Scan

Study Details

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

Study ID

NCT04054310

Start date

Aug 5, 2020

Status verified date

May, 2026

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

225 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Study-gate

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

Interventions

Liver Multi Scan

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

Primary outcome measure

  • Diagnostic performance of cT1 [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Cayden Beyer

01865655343cayden.beyer@perspectum.com

Locations

Arizona Liver Health

Recruiting

Chandler, Arizona, United States, 85224

Contacts

David Rios, MD

drios@azliver.com

Principal Investigator:

Naim Alkhouri, MD

RUSH University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Lelani Fetrow, BSN

Lelani_C_Fetrow@rush.edu

Principal Investigator:

Nancy Reau, MD

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sreemala Murthy, BSc

srmurthy@iu.edu

Principal Investigator:

Raj Vuppalanchi, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Elianna Sanchez

elianna.sanchez@mssm.edu

Principal Investigator:

Douglas Dieterich

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Cheree Denbee

cjd4a@hscmail.mcc.virginia.edu

Principal Investigator:

Zachary Henry

Virginia Common wealth University

Recruiting

Richmond, Virginia, United States, 23284

Contacts

Arun Sanyal, MD

8048284060arun.sanyal@vcuhealth.org

Rebecca Collen, BSC

8048280100rebeccs.collen@vcuhealth.org

Principal Investigator:

Arun Sanyal

More Information

Sponsor

Perspectum

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Perspectum on 2026-05-19.