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

NCT03342560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-10-28

Study results available
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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)

Conditions

Interventions

DEVICE

Sonographic SWE measurements with 4 different ultrasound systems

Sonographic Shear wave elastography will be performed to quantify liver fibrosis

Sponsors & Collaborators

  • Canon Medical Systems, USA

    collaborator INDUSTRY

  • Siemens Medical Solutions

    collaborator INDUSTRY

  • Radiological Society of North America

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Anthony E. Samir, MD, MPH · Associate Medical Director, Ultrasound Imaging Services

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2018-08-14
Completion
2018-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03342560 on ClinicalTrials.gov