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

University of California, San Diego1 site in 1 country30 target enrollmentMay 21, 2019

ConditionsNonalcoholic Fatty Liver Nonalcoholic Steatohepatitis Liver Fibroses Liver Inflammation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nonalcoholic Fatty Liver
Sponsor: University of California, San Diego
Enrollment: 30
Locations: 1
Primary Endpoint: Accuracy of MRE and c-T1 to assess disease progress
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

May 21, 2019

End Date

July 12, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University of California, San Diego

Responsible Party

Principal Investigator

Claude Sirlin

Professor

University of California, San Diego

Eligibility Criteria

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