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

NCT ID: NCT04389593

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-21

Study Completion Date

2024-07-12

Brief 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.

Detailed Description

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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.

Conditions

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Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis Liver Fibroses Liver Inflammation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Single arm

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Claude Sirlin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claude B Sirlin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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181449

Identifier Type: -

Identifier Source: org_study_id

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