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Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

Primary Purpose

Liver Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mechanical Vibrations with Ultrasound Shear Wave Imaging
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Liver Fibrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mechanical Vibrations with Ultrasound Shear Wave Imaging

Arm Description

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

Outcomes

Primary Outcome Measures

Liver Stiffness Measured by MRE
Liver stiffness measured by standard of care Magnetic Resonance Elastography reported in Kilopascals (kPa) (used as a benchmark reference in this study).
Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging
Liver stiffness measured by Mechanical Vibrations with Ultrasound Shear Wave Imaging reported in kilopascal (kPa).

Secondary Outcome Measures

Full Information

First Posted
August 14, 2018
Last Updated
December 10, 2021
Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03637959
Brief Title
Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging
Official Title
Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
November 4, 2020 (Actual)
Study Completion Date
November 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigao Chen, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

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