Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

Mayo Clinic

Status: Completed

Conditions: Liver Fibrosis

Treatments: Device: Mechanical Vibrations with Ultrasound Shear Wave Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03637959

13-002289

R01DK106957 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

Mechanical Vibrations with Ultrasound Shear Wave Imaging

Experimental group

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

Treatment:

Device: Mechanical Vibrations with Ultrasound Shear Wave Imaging