Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

Not Applicable

Completed

• Conditions: Liver Fibrosis
• Interventions: Device: Mechanical Vibrations with Ultrasound Shear Wave Imaging

• Registration Number: NCT03637959
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2017-01-26
• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Results First Submitted: 2021-10-27
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-10
• Last Update Submitted: 2021-12-10
• Results First Posted: 2021-12-13
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mechanical Vibrations with Ultrasound Shear Wave Imaging	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

Primary Outcome Measures

Name	Time	Method
Liver Stiffness Measured by MRE	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).
Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging	Baseline, approximately 1 day	Liver stiffness measured by Mechanical Vibrations with Ultrasound Shear Wave Imaging reported in kilopascal (kPa).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States