Chronic Liver Disease
Conditions
Brief summary
A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to quantify liver stiffness in children and young adults with chronic liver disease. ARFI results will be compared to the current clinical standard of Magnetic Resonance Elastography (MRE) and to liver biopsy when available.
Detailed description
ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness. ARFI US has been shown in a small pilot investigation in Europe in children to be reliable and rapid in estimating moderate to severe liver stiffness using histology as a reference gold standard. ARFI measures the speed of a shear wave in the examined tissue, expressed in m/s. This shear wave velocity can be mathematically converted into a liver stiffness value, which can then be used to estimate degree of liver fibrosis. The technique is non-invasive, uses no ionizing radiation, and is fast (several minutes to complete). It is possible that ARFI US will be more accurate than MRE in quantifying liver stiffness. In addition, ARFI US will ultimately be a less expensive clinical test, shorter in duration, and will not require sedation/anesthesia in younger children as MRE requires.
Interventions
DEVICEAcoustic Radiation Force Imaging
ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.
Sponsors
Siemens Medical Solutions
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 25 Years
Healthy volunteers
No
Inclusion criteria
* Less than 25 years old with chronic liver disease
Exclusion criteria
* Subjects without clinically ordered MRE * Subjects who cannot cooperate with performance of the short ARFI exam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement in Measured Liver Stiffness Between ARFI and MRE | Within 24 hours | The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Cohort Acoustic Radiation Force Imaging
Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Study Cohort | — |
|---|---|---|
| Age, Continuous | 14 years STANDARD_DEVIATION 3.9 | — |
| BMI | 29.1 kg/m2 STANDARD_DEVIATION 8.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 55 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 31 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
Agreement in Measured Liver Stiffness Between ARFI and MRE
The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis
Time frame: Within 24 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMI <30 kg/m2 | Agreement in Measured Liver Stiffness Between ARFI and MRE | Mean Stiffness by ARFI | 1.81 kPa |
| BMI <30 kg/m2 | Agreement in Measured Liver Stiffness Between ARFI and MRE | Mean Stiffness by MRE | 3.21 kPa |
| BMI >30kg/m2 | Agreement in Measured Liver Stiffness Between ARFI and MRE | Mean Stiffness by ARFI | 2.0 kPa |
| BMI >30kg/m2 | Agreement in Measured Liver Stiffness Between ARFI and MRE | Mean Stiffness by MRE | 2.48 kPa |
Primary
Agreement in Measured Liver Stiffness Between ARFI and MRE
The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis
Time frame: Within 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMI <30 kg/m2 | Agreement in Measured Liver Stiffness Between ARFI and MRE | 0.61 Correlation Coefficient (rho) |
| BMI >30kg/m2 | Agreement in Measured Liver Stiffness Between ARFI and MRE | 0.07 Correlation Coefficient (rho) |