Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology as Reference

This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.

Study Overview

• Status: Recruiting
• Conditions: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver; Liver Inflammation; Liver Fibroses

Detailed Description

This prospective pilot study evaluates the comparative and additive diagnostic performance of Magnetic Resonance Elastography (MRE) and corrected-T1 (cT1) for the detection and staging of fibrosis and inflammation in Nonalcoholic Steatohepatitis (NASH), using histology as the reference standard.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Alexandra Schlein; Phone Number: (858) 246- 2199; Email: a1schlein@health.ucsd.edu
• Study Contact Backup: Name: Yesenia Covarrubias; Phone Number: (858) 246 - 2198; Email: ycovarrubias@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University of California, San Diego
      • Contact: Alexandra Schlein; Phone Number: 858-246-2199; Email: a1schlein@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with known or suspected NASH

Description

Inclusion Criteria:

• Adult subjects of any gender and any ethnic group with known or suspected NASH
• Subject is willing and able to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, and research MRI exam), and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images and clinical or research biopsy results
• Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents
• Subject has had or is expected to have a clinical or research biopsy within 150 days of the MR exam

Exclusion Criteria:

• VA subject
• < 18 years of age
• Subject does not have a physician and does not wish to be contacted about possible incidental findings
• MRI contraindication(s)
• Subject knows that she is pregnant or states she is trying to become pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single arm; This is a single arm study in which all participants have one MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of MRE and c-T1 to assess disease progress	The positive predictive value of quantitative imaging will be compared to histology for the assessment of NASH.	up to one year

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Claude B Sirlin, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Inflammation; Hepatitis; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 181449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No