RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study

Quick Facts

Study Start:2020-08-05

Study Completion:2024-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04054310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Bryn Horsington, BSc.

CONTACT

01865655343

bryn.horsington@perspectum.com

Principal Investigator

Arun Sanyal, M.D.

PRINCIPAL_INVESTIGATOR

VCU School of Medicine

Study Locations (Sites)

Arizona Liver Health

Chandler, Arizona, 85224

United States

RUSH University Medical Center

Chicago, Illinois, 60612

United States

Indiana University Health

Indianapolis, Indiana, 46202

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Liver Center of Texas

Dallas, Texas, 75234

United States

University of Virginia

Charlottesville, Virginia, 22908

United States

Virginia Common wealth University

Richmond, Virginia, 23284

United States

Collaborators and Investigators

Sponsor: Perspectum

Arun Sanyal, M.D., PRINCIPAL_INVESTIGATOR, VCU School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-05

Study Completion Date2024-05-01

Study Record Updates

Study Start Date2020-08-05

Study Completion Date2024-05-01

Terms related to this study

Additional Relevant MeSH Terms

NASH - Nonalcoholic Steatohepatitis