Status:
COMPLETED
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
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
GE Healthcare
Conditions:
Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-90 years
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 12 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04389593
Start Date
May 21 2019
End Date
July 12 2024
Last Update
November 25 2024
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92037