A Study to Evaluate Liver Stiffness With Shear Wave Elastography

Status Completed

Clinical Trial Summary

The purpose of the study is to assess the diagnostic accuracy of Endoscopic Ultrasound (EUS) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis

Clinical Trial Description

This is a prospective, paired study. Study subjects who are scheduled to undergo EUS at Mayo Clinic will be identified through Epic. Chart review will be performed including review of prior imaging, medical history, and laboratory results as available in Epic to determine study eligibility. Subjects without history of chronic liver disease (screened by low FIB-4 score) and those with known advanced fibrosis/cirrhosis will be eligible for the study. Eligible study subjects will then be contacted either before, or at the time of their endoscopy procedure to discuss study participation. All subjects will then receive standard clinical care based on the indication for the EUS procedure. During the EUS procedure, study subjects with undergo shear wave measurements obtained in a non-invasive manner as part of the endosonographic evaluation of the liver. 10 measurements (including shear wave velocity (Vs), elastic modulus (E)) will be obtained for point SWE (pSWE). Measurements will be obtained from both left and right lobes of liver unless technically infeasible to do so. Study subjects will then undergo a paired MR elastography (same day or at later date) after completion of EUS and only if consistent and reliable shear wave measurements were obtained (e.g., VsN > 70%(reliability index of each measurement expressed in percentages), IQR/M (interquartile range/ Median) is <15% for Vs and <30% for E). Enrolled study subjects who had undergone a previous MRE (within 6 months of enrollment) would be eligible for the study, without the need to undergo further research MRE. After completion of MR elastography, the subjects will then continue through their routine clinical care and will not be followed up by research staff. The expected duration of subject participation is anticipated to begin at the time of study enrollment and terminate after completion of MR elastography. There will be no additional follow up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05097963
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	N/A
Start date	January 19, 2022
Completion date	January 12, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.