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

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Updated on 19 February 2024

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fibrosis

MRI

elastography

fatty liver

nash

steatohepatitis

magnetic resonance elastography

Summary

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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 Identifier	NCT04389593
Sponsor	University of California, San Diego
Last Modified on	19 February 2024

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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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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