Trial Outcomes & Findings for Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging (NCT NCT03637959)

Last Updated: 2021-12-13

Results Overview

Liver stiffness measured by standard of care Magnetic Resonance Elastography reported in Kilopascals (kPa) (used as a benchmark reference in this study).

Recruitment status

COMPLETED

Study phase

Target enrollment

270 participants

Primary outcome timeframe

Baseline, approximately 1 day

Results posted on

2021-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	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 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.
Overall Study STARTED	270
Overall Study COMPLETED	270
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mechanical Vibrations With Ultrasound Shear Wave Imaging n=270 Participants 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 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.
Age, Continuous	52.1 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	256 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	250 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United States	270 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Mechanical Vibrations With Ultrasound Shear Wave Imaging n=270 Participants 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 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.
Liver Stiffness Measured by MRE	3.07 kPa Standard Deviation 1.36

PRIMARY outcome

Timeframe: Baseline, approximately 1 day

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

Outcome measures

Outcome measures
Measure	Mechanical Vibrations With Ultrasound Shear Wave Imaging n=270 Participants 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 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.
Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging	2.66 kPa Standard Deviation 1.00

Adverse Events

Mechanical Vibrations With Ultrasound Shear Wave Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shigao Chen, Ph.D.

Mayo Clinic

Phone: 507-284-3703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place