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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    University of California, San Diego
Updated on 19 February 2024
fibrosis
MRI
elastography
fatty liver
nash
steatohepatitis
magnetic resonance elastography

Summary

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

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.

Details
Condition Cirrhosis, Hepatitis, Hepatitis, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver
Age 18years - 90years
Clinical Study IdentifierNCT04389593
SponsorUniversity of California, San Diego
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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