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| Name | Class |
|---|---|
| Siemens Medical Solutions | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | Experimental | Acoustic Radiation Force Imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoustic Radiation Force Imaging | Device | ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Trout, M.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Presenting for MR elastography
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | kPa | Within 24 hours |
|
Study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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1)Did not compare ARFI from multiple vendors to MR elastography, 2)No histologic reference standard
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew T. Trout, MD | Cincinnati Children's Hospital Medical Center | 513-803-3004 | andrew.trout@cchmc.org |
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| ID | Term |
|---|---|
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m2 |
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| Units | Counts |
|---|---|
| Participants |
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| 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 | Posted | Number | Correlation Coefficient (rho) | Within 24 hours |
|
|
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| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
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