Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

December 10, 2021 updated by: Shiago Chen, Mayo Clinic
The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting ultrasound liver tissue elastography measurements during participant breath holds. Participants fast for a minimum of four hours and are positioned lying on left side with knees slightly bent.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers or patients who are scheduled for clinically indicated liver MRE for fibrosis staging.
  • Age 18 to 80.

Exclusion Criteria:

  • Subjects lacking capacity to consent
  • Subjects with unreliable ultrasound or MRE measurements.
  • Pregnant women.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechanical Vibrations with Ultrasound Shear Wave Imaging
Subjects that are scheduled to undergo a clinical indicated Magnetic Resonance Elastography (MRE) will also have mechanical vibrations ultrasound shear wave imaging to measure liver stiffness
Device: Mechanical Vibrations with Ultrasound Shear Wave Imaging
Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Stiffness Measured by MRE
Time Frame: Baseline, approximately 1 day
Liver stiffness measured by standard of care Magnetic Resonance Elastography reported in Kilopascals (kPa) (used as a benchmark reference in this study).
Baseline, approximately 1 day
Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging
Time Frame: Baseline, approximately 1 day
Liver stiffness measured by Mechanical Vibrations with Ultrasound Shear Wave Imaging reported in kilopascal (kPa).
Baseline, approximately 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Shigao Chen, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

January 26, 2017

Primary Completion (Actual)

November 4, 2020

Study Completion (Actual)

November 4, 2020

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-002289
  • R01DK106957 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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