Liver Fibrosis
Conditions
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.
Interventions
DEVICEMechanical 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Stiffness Measured by MRE | 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). |
| Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging | Baseline, approximately 1 day | Liver stiffness measured by Mechanical Vibrations with Ultrasound Shear Wave Imaging reported in kilopascal (kPa). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 270 |
| Total | 270 |
Baseline characteristics
| Characteristic | Mechanical Vibrations With Ultrasound Shear Wave Imaging |
|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 15.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 256 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 250 Participants |
| Region of Enrollment United States | 270 participants |
| Sex: Female, Male Female | 130 Participants |
| Sex: Female, Male Male | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 270 |
| other Total, other adverse events | 0 / 270 |
| serious Total, serious adverse events | 0 / 270 |
Outcome results
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).
Time frame: Baseline, approximately 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mechanical Vibrations With Ultrasound Shear Wave Imaging | Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging | 2.66 kPa | Standard Deviation 1 |
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).
Time frame: Baseline, approximately 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mechanical Vibrations With Ultrasound Shear Wave Imaging | Liver Stiffness Measured by MRE | 3.07 kPa | Standard Deviation 1.36 |