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ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.
A new technique based on ultrasound, known as Acoustic Radiation Force Impulse (ARFI) imaging is performed using standard approved ultrasound machines and transducers. The sound waves or impulses are generated in a different pattern and offer information on the stiffness of the tissue. This new technique will be evaluated for usefulness in diagnosing different liver conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-based Acoustic Radiation Force Imaging | Experimental | The liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-Based Acoustic Radiation Force Impulse (ARFI) | Device | Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively. |
| Measure | Description | Time Frame |
|---|---|---|
| ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score | Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures. Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis. | 10 minutes |
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Inclusion Criteria:
18 years of age or younger
Scheduled to have a needle biopsy of the liver at
Scheduled to have an abdominal ultrasound to evaluate your liver (with no known liver disease)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Dillman, M.D. | University of Michigan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
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Pediatric patients aged 18 and younger were scheduled for a liver biopsy at a large pediatric hospital between 2012 and 2014. A total of 62 patients were recruited and enrolled. Patients and their parents gave consent/assent for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound-based Acoustic Radiation Force Impulse (ARFI) | 62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy were included. Biopsy was performed for known or suspected (non-neoplastic) liver disease. (One child did not undergo a liver biopsy, so was ineligible and not included in the above total.) The patients received an additional ultrasound for research purposes that utilized a technique known as ARFI. ARFI, or Acoustic Radiation Force Impulse, uses a transducer which directs sound waves again the liver to measure the stiffness of the tissues. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children undergoing percutaneous core needle liver biopsy
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound-based Acoustic Radiation Force Impulse (ARFI) | 62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy for known or suspected (non-neoplastic) liver disease were included in this study. Subjects were between 0-18 years of age. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score | Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures. Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis. | 49 pediatric subjects underwent successful (diagnostic) liver ARFI/VTQ) assessment and liver histologic fibrosis scoring. 13 subjects had non-diagnostic ARFI/VTQ exams. 48 pediatric subjects underwent successful (diagnostic) liver ARFI/VTIQ) assessment and liver histologic fibrosis scoring. 14 subjects had non-diagnostic ARFI/VTIQ exams. | Posted | Mean | Standard Deviation | m/s | 10 minutes |
|
19 months
There were no adverse events
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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 | All Participants | No serious or non-serious adverse events were observed during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Dillman, MD | Cincinnati Children's Hospital Medical Center, Department of Radiology | 513 803-7114 | jonathan.dillman@cchmc.org |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
We measured correlation between liver shear wave speed as determined by ARFI (VTQ) and liver histologic fibrosis score. |
| OG001 | Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring | We measured correlation between liver shear wave speed as determined by ARFI/VTIQ and liver histologic fibrosis score. |
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| 0 |
| 62 |
| 0 |
| 62 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |