Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography
NCT ID: NCT03342560
Last Updated: 2019-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-06-29
2018-08-30
Brief Summary
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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)
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Detailed Description
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Fibrotic livers demonstrate increased stiffness, a property that can be measured using technology named Ultrasound Elastography or sonoelastography (SWE). SWE is performed by insonating the patient with a low energy, amplitude, and frequency shear wave created by a vibrating probe. The propagated wave travels faster with increasing fibrosis: the stiffer the tissue, the faster the shear wave propagates. A pulse-echo ultrasound acquisition allows measurement of the wave velocity and the results are presented as kilopascals (kPa). Prior reports have described sensitivity and specificity for liver fibrosis detection of 80% and 97% respectively for SWE. The benefits of SWE are that it is inexpensive, reproducible, painless, rapid (\< 10 min), easy to perform, and can be used for diagnosis, prognosis and monitoring disease progression.
The objective of this study is to compare the variation in elastography values and study the factors that might cause these variations.
The proposed investigation is a cross-sectional study using ultrasound elastography. 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.
All subjects will be required to come to the MGH main campus for 2 study visits within 60 days of each other. In addition, subjects will need to fast for at least 4 hours prior to study visits
There will be two visits in this study and maximum 60 days time frame between the visits is anticipated. Two operators will perform the ultrasound examination. Reproducibility and repeatability of the ultrasound devices will be estimated.
Ultrasound examination including sonoelastography will be performed using four FDA-approved ultrasound units; Both operators will perform;
* Median Elastograpy (10 measurements) on regular and variable map at a depth(in the area between 2cm from capsule and 6.5cm from skin)
* Median SWE value with active/free breath(10measurements)
* Median SWE value with less number of acquisitions(3measurements)
These measurements will be collected in subgroups using specific systems. In second visit, all measurements will be repeated with the same operators.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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30 Patients with known liver biopsy results
Patients with chronic liver disease with known biopsy results
Sonographic SWE measurements with 4 different ultrasound systems
Sonographic Shear wave elastography will be performed to quantify liver fibrosis
Interventions
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Sonographic SWE measurements with 4 different ultrasound systems
Sonographic Shear wave elastography will be performed to quantify liver fibrosis
Eligibility Criteria
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Inclusion Criteria
* Men or Woman
* Suspected diffuse liver disease and have had a liver biopsy within the last 6 months or are scheduled for a liver biopsy in the next 3 months.
* Consent to participate in the study
Exclusion Criteria
* Acute illness/ cognitive impairment resulting in inability to cooperate with ultrasound
* Patients that do not consent to ultrasound examination
18 Years
ALL
No
Sponsors
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Canon Medical Systems, USA
INDUSTRY
Siemens Medical Solutions
INDUSTRY
Radiological Society of North America
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Anthony Samir
Service Chief,Body Ultrasound Department of Radiology, Assistant Professor at Harvard Medical School
Principal Investigators
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Anthony E. Samir, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Associate Medical Director, Ultrasound Imaging Services
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017P000940
Identifier Type: -
Identifier Source: org_study_id
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