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NCT04389593 Clinical Trial

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

Nonalcoholic Steatohepatitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04389593
Other study ID # 181449
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 21, 2019
Est. completion date August 31, 2024

Study information
Verified date December 2023
Source University of California, San Diego
Contact Alexandra Schlein
Phone (858) 246- 2199
Email a1schlein@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of California, San Diego La Jolla California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of MRE and c-T1 to assess disease progress The positive predictive value of quantitative imaging will be compared to histology for the assessment of NASH. up to one year
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