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
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 |
This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
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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