CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Sonographic SWE measurements with 4 different ultrasound systemsdevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03342560
NCT03342560N/ACompleted

Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography

Massachusetts General Hospital·interventional·Posted Nov 17, 2017·Updated Oct 28, 2019

In Brief

A clinical study evaluating Sonographic SWE measurements with 4 different ultrasound systems for Liver Fibrosis and Liver Diseases. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize that variation using ultrasound elastography for the estimation of stage of liver fibrosis and steatosis in patients with diffuse liver disease exists due to different methods of measurements, and/or different systems. The proposed investigation is a cross-sectional study using ultrasound elastography and fat quantification modalities. The investigators are planning to enroll 30 subjects 18 years old and older in whom diffuse liver disease is suspected, and who have undergone non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3 months of enrollment, as part of their routine clinical care. The investigators will use 4 different ultrasound devices with their shear wave elastography and speed of sound functions. Specific aims; * Compare shear wave elastography(SWE) measurements from different ultrasound systems; using histopathology as reference standards. * Assess intra-operator and inter-operator reliability by measuring variability in elastography values by two operators on a single system. * Determine the effect of deviations from guidelines(less number of measurements and measurements during active breath)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartJun 29, 2017
Primary CompletionAug 14, 2018
Study CompletionAug 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.6 years ago

Interventions

Sonographic SWE measurements with 4 different ultrasound systemsdevice

Sonographic Shear wave elastography will be performed to quantify liver fibrosis