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

a study on Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Steatohepatitis Liver Fibroses Liver Inflammation Fibrosis Cirrhosis Liver Disease Hepatitis

Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Claude B Sirlin, MD (ucsd)
Headshot of Claude B Sirlin
Claude B Sirlin

Description

Summary

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

Details

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.

Keywords

Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Liver Fibroses, Liver Inflammation, Fatty Liver, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Hepatitis, Inflammation, Fibrosis

Eligibility

You can join if…

Open to people ages 18-90

  • 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 CAN'T join 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

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92037 United States

Lead Scientist at University of California Health

  • Claude B Sirlin, MD (ucsd)
    Professor, Radiology, Vc-health Sciences-schools. Authored (or co-authored) 446 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04389593
Study Type
Observational
Participants
Expecting 30 study participants
Last Updated