- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04389593
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
December 1, 2023 updated by: Claude Sirlin, University of California, San Diego
This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.
Study Overview
Status
Recruiting
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 inflammation in Nonalcoholic Steatohepatitis (NASH), using histology as the reference standard.
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexandra Schlein
- Phone Number: (858) 246- 2199
- Email: a1schlein@health.ucsd.edu
Study Contact Backup
- Name: Yesenia Covarrubias
- Phone Number: (858) 246 - 2198
- Email: ycovarrubias@health.ucsd.edu
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Recruiting
- University of California, San Diego
-
Contact:
- Alexandra Schlein
- Phone Number: 858-246-2199
- Email: a1schlein@health.ucsd.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adults with known or suspected NASH
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Single arm
This is a single arm study in which all participants have one MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of MRE and c-T1 to assess disease progress
Time Frame: up to one year
|
The positive predictive value of quantitative imaging will be compared to histology for the assessment of NASH.
|
up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Claude B Sirlin, MD, University of California, San Diego
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2019
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
May 11, 2020
First Posted (Actual)
May 15, 2020
Study Record Updates
Last Update Posted (Estimated)
December 5, 2023
Last Update Submitted That Met QC Criteria
December 1, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181449
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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