Under 18, any sex, with Sonoelastography or Elastography. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on METAVIR Scoring SystemPrimary· 2 years
METAVIR score is a tool used to measure fibrosis as seen on liver biopsy and scored to describe liver disease progress and prognosis.
Sensitivity
Group
Value
95% CI
Controls+METAVIR 0
NA
METAVIR F1
96.9
METAVIR F2
95.2
METAVIR F3
1.00
Specificity
Group
Value
95% CI
Controls+METAVIR 0
NA
METAVIR F1
80.2
METAVIR F2
70.7
METAVIR F3
64.1
PPV
Group
Value
95% CI
Controls+METAVIR 0
NA
METAVIR F1
66.0
METAVIR F2
42.6
METAVIR F3
21.3
NPV
Group
Value
95% CI
Controls+METAVIR 0
NA
METAVIR F1
98.5
METAVIR F2
98.5
METAVIR F3
1.00
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on Ishak Scoring SystemPrimary· 2 years
Ishak is a tool used to evaluate liver fibrosis via liver biopsy to report severity and prognosis of liver disease, specifically hepatitis.
Sensitivity
Group
Value
95% CI
Control + Ishak 0
NA
Ishak 1
93.8
Ishak 2
95.8
Ishak 3
95.2
Ishak 4
100.0
Specificity
Group
Value
95% CI
Control + Ishak 0
NA
Ishak 1
79.0
Ishak 2
73.0
Ishak 3
70.7
Ishak 4
62.3
PPV
Group
Value
95% CI
Control + Ishak 0
NA
Ishak 1
63.8
Ishak 2
48.9
Ishak 3
42.6
Ishak 4
14.9
NPV
Group
Value
95% CI
Control + Ishak 0
NA
Ishak 1
96.9
Ishak 2
98.5
Ishak 3
98.5
Ishak 4
100.0
Sponsor's own description
Reliable methods of evaluating liver fibrosis using noninvasive techniques in the pediatric population are limited and inconclusive. Liver biopsy remains the gold standard; however, it requires sedation in pediatric patients, has a risk of hemorrhage, and provides unreliable results secondary to sampling error. Sonoelastography is a new method of evaluating liver disease that eliminates these pitfalls. There are 3 types of quantitative sonoelastography currently in use.
Transient elastography is a non-imaging based technique used in adults to measure liver fibrosis in which a mechanical vibrator creates a low-frequency wave causing shear stress in the liver at a fixed depth. This technique does not work in small livers and, therefore, is not appropriate for pediatric patients.
Acoustic Radiation Force Impulse Imaging (ARFI) and Shear Wave Imaging (SWE) use real-time ultrasonography and administer focused high-intensity, short-duration pulses to produce shear waves in the liver tissue. ARFI calculates the degree of tissue displacement and creates an elastogram or measurement of the stiffness of the sampled liver tissue without corresponding images. It is limited since only a small sample or region of interest (ROI) can be obtained, and it is unable to provide a corresponding elasticity map of the tissue.
SWE is the newest elastography technique. It measures tiny displacements of tissue in a larger ROI with corresponding ultrasound images which provides a side by side image of the liver and color-coded elasticity map of the sampled tissue. Advantages include a larger ROI and simultaneous viewing of the selected region of interest which provides better anatomic detail with a corresponding color map of the tissue elasticity which may result in more accurate scoring of the stage of fibrosis.
There are a few studies of ARFI in the pediatric population. Studies using SWE for evaluation of liver fibrosis are also few, and, all but one in adults. However, these studies have shown it to be an accurate method for liver fibrosis staging. Use of SWE in assessing liver fibrosis in pediatric patients may represent an accurate noninvasive alternative to liver biopsy in evaluating liver fibrosis as well as avoid the use of sedation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by St. Louis University
Last refreshed: 12 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02372682.