A Study to Evaluate Liver Stiffness With Shear Wave Elastography

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05097963

Collaborator

(none)

Enrollment

Location

Arm

10.4

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Chronic Liver Disease Advanced Fibrosis Advanced Cirrhosis	Device: Endoscopic Ultrasound Shear Wave Elastography	N/A

Detailed 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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Prospective Study of Endoscopic Ultrasound Shear Wave Elastography for Assessment of Liver Fibrosis

Actual Study Start Date :

Jan 19, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects undergoing EUS shear wave elastography Subject who are eligible will undergo EUS for clinical indications. EUS shear wave measurements will be gathered and studied to determine diagnostic accuracy when compared to MR Elastography.	Device: Endoscopic Ultrasound Shear Wave Elastography Software to determine stiffness of liver for evaluating liver fibrosis.

Arm

Intervention/Treatment

Experimental: Subjects undergoing EUS shear wave elastography

Subject who are eligible will undergo EUS for clinical indications. EUS shear wave measurements will be gathered and studied to determine diagnostic accuracy when compared to MR Elastography.

Device: Endoscopic Ultrasound Shear Wave Elastography

Software to determine stiffness of liver for evaluating liver fibrosis.

Outcome Measures

Primary Outcome Measures

Assessing the diagnostic accuracy of EUS shear wave elastography for assessment of liver fibrosis. [6-9 months]
To assess the diagnostic accuracy of EUS shear wave elastography in liver fibrosis staging in both normal subject and subject with advanced liver fibrosis/cirrhosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults over 18 years of age who are undergoing EUS procedures.
Subjects with history of chronic liver disease, advanced fibrosis or cirrhosis
Subjects without any history of chronic liver disease
Subjects who underwent MR elastography within six (6) months of enrollment will be eligible to participate in the study.
Subjects able to give appropriate consent to the study or have an appropriate representative to do so.

Exclusion Criteria:

Subjects who may have MRI-incompatible metal implants/devices.
Subjects with severe claustrophobia who may not tolerate MR elastography.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Vinay Chandrasekhara, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Vinay Chandrasekhara, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05097963

Other Study ID Numbers:

21-003779

First Posted:

Oct 28, 2021

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Liver Diseases

Fibrosis

Study Results

No Results Posted as of Aug 17, 2022