Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

Liver Fibrosis Clinical Trial

Official title:

Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637959
• Other study ID #: 13-002289
• Secondary ID: R01DK106957
• Status: Completed
• Phase: N/A
• Start date: January 26, 2017
• Est. completion date: November 4, 2020

Study information

• Verified date: December 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, approximately 1 day
Primary	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).	Baseline, approximately 1 day

External Links

•   Mayo Clinic Clinical Trials