Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

NCT03637959 | Completed Results FDA Device

• 2 other identifiers: 13-002289R01DK106957
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Mechanical Vibrations with Ultrasound Shear Wave Imaging

EXPERIMENTAL

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

Device: Mechanical Vibrations with Ultrasound Shear Wave Imaging

Interventions

Mechanical Vibrations with Ultrasound Shear Wave Imaging DEVICE

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.

Mechanical Vibrations with Ultrasound Shear Wave Imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers or patients who are scheduled for clinically indicated liver MRE for fibrosis staging.
• Age 18 to 80.

You may not qualify if:

• Subjects lacking capacity to consent
• Subjects with unreliable ultrasound or MRE measurements.
• Pregnant women.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Shigao Chen, Ph.D.
• Organization: Mayo Clinic

Chen.Shigao@mayo.edu

507-284-3703

Study Officials

• Shigao Chen, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 20, 2018
• Study Start: January 26, 2017
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: December 13, 2021
• Results First Posted: December 13, 2021

Record last verified: 2021-12

Locations

US (1)