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NCT Number: NCT04389593

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

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

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Key information

Conditions

Nonalcoholic Fatty Liver Digestive System Diseases Fatty Liver Fibrosis Hepatitis Liver Cirrhosis Liver Diseases Liver Fibroses Liver Inflammation Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Accuracy of MRE and c-T1 to assess disease progress

    Time frame: up to one year

    The positive predictive value of quantitative imaging will be compared to histology for the assessment of NASH.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 15, 2020
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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