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

Completed

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

• Registration Number: NCT04389593
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2019-05-21
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-15
• Primary Completion: 2024-07-12
• Study Completion: 2024-07-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States