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Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

Not Applicable
Completed
Conditions
Liver Fibrosis
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.

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
Primary Outcome Measures
NameTimeMethod
Liver Stiffness Measured by MREBaseline, 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 ImagingBaseline, approximately 1 day

Liver stiffness measured by Mechanical Vibrations with Ultrasound Shear Wave Imaging reported in kilopascal (kPa).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Mayo Clinic
🇺🇸Rochester, Minnesota, United States
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