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 Diego

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04389593

181449

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Single arm

Description:

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