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

NCT04389593 | Completed

• 1 other identifier: 181449
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis; Liver Fibroses; Liver Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single arm

This is a single arm study in which all participants have one MRI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with known or suspected NASH

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• GE Healthcare: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Hepatitis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claude B Sirlin, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: May 15, 2020
• Study Start: May 21, 2019
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)