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The technology showed rapid acceptance in the general population and we halted our feasibility demonstration study.
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HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.
Specific Aims:
To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shear Wave Sonoelastography, Fibrosis stage | Experimental | Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shear Wave sonoelastography | Device | Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score of fibrosis from liver biopsy. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Liver Elasticity Value Using Sonoelastography. | Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4). | Day one |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uzma Shah, MD, FAAP | Massachusetss General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26503488 | Result | Dhyani M, Gee MS, Misdraji J, Israel EJ, Shah U, Samir AE. Feasibility study for assessing liver fibrosis in paediatric and adolescent patients using real-time shear wave elastography. J Med Imaging Radiat Oncol. 2015 Dec;59(6):687-94; quiz 751. doi: 10.1111/1754-9485.12388. Epub 2015 Oct 27. |
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1. Patients scheduled for Liver Biopsy 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Shear Wave Sonoelastography, Fibrosis | Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy. Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pediatric and Adolescents
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| ID | Title | Description |
|---|---|---|
| BG000 | Shear Wave Sonoelastography, Fibrosis | Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy. Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | In this study:
|
| 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 | Measure Liver Elasticity Value Using Sonoelastography. | Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4). | Posted | Mean | 95% Confidence Interval | kPa | Day one |
|
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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 | Fibrosis 0 | Patients with no Fibrosis on liver biopsy evaluation |
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This was meant to be a feasibility study to show that shear-wave sonoelastography can be performed in the pediatric age group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Uzma Shah | Massachusetts General Hospital | 617-726-1450 | USHAH@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D056486 | Chemical and Drug Induced Liver Injury |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
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|
| Mean |
| Full Range |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients with liver biopsy METAVIR stage 2 on pathology evaluation
| OG003 | Fibrosis 3 | Patients with liver biopsy METAVIR stage 3 on pathology evaluation |
| OG004 | Fibrosis 4 | Patients with liver biopsy METAVIR stage 4 on pathology evaluation |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Fibrosis 1 | Patients with liver biopsy METAVIR stage 1 on pathology evaluation | 0 | 9 | 0 | 9 |
| EG002 | Fibrosis 2 | Patients with liver biopsy METAVIR stage 2 on pathology evaluation | 0 | 1 | 0 | 1 |
| EG003 | Fibrosis 3 | Patients with liver biopsy METAVIR stage 3 on pathology evaluation | 0 | 3 | 0 | 3 |
| EG004 | Fibrosis 4 | Patients with liver biopsy METAVIR stage 4 on pathology evaluation | 0 | 1 | 0 | 1 |
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| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |