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
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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COMPLETED
30 participants
OBSERVATIONAL
2019-05-21
2024-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
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
* 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
* \< 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
18 Years
90 Years
ALL
No
Sponsors
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GE Healthcare
INDUSTRY
University of California, San Diego
OTHER
Responsible Party
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Claude Sirlin
Professor
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
Countries
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Other Identifiers
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181449
Identifier Type: -
Identifier Source: org_study_id
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