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

NCT03342560 | Completed Results DMC FDA Device

• 1 other identifier: 2017P000940
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Liver Fibrosis; Liver Diseases

Keywords

Liver Fibrosis; Ultrasound Elastography; Shear wave speed; Stiffness; Liver Biopsy

Outcome Measures

Primary Outcomes (2)

• Deviations From Suggested Guidelines- Any Effect on Agreement

  We collected guideline suggested shear wave elastography measurements from 20 patients. Guidelines suggest collecting 1) 10 measurements, 2) Asking patient to hold breath during the measurements. As a deviation from guideline suggestions, we collected measurements during free breath movements without asking patient to hold breath. As a deviation from the guideline suggestions, fewer number of measurements (3 measurements) were collected with asking the patient to hold breath during the measurements. All measurements were collected using one type of ultrasound system. All measurements were collected by 2 operators in 2 visits.

  Visit 1 and Visit 2, an average of 2.5 hours for each visit

• Interoperator and Intraoperator Agreement in m/s and kPA Units

  In 20 patients we collected 10 shear wave elastography measurements in m/s and kPA units. Using one of the available ultrasound systems, 2 operators collected these measurements in 2 visits. Theoretically, m/s to kPA conversion can be made using an equation. However, some systems provide opportunity to get data in both units. Although algebraically m/s and kPA can be converted to each other, we found some minor differences in terms of inter-operator and intra-operator agreement.

  Visit 1 and Visit 2, an average of 2.5 hours for each visit

Study Arms (1)

30 Patients with known liver biopsy results

EXPERIMENTAL

Patients with chronic liver disease with known biopsy results

Device: Sonographic SWE measurements with 4 different ultrasound systems

Interventions

Sonographic SWE measurements with 4 different ultrasound systems DEVICE

Sonographic Shear wave elastography will be performed to quantify liver fibrosis

30 Patients with known liver biopsy results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patients
• 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

You may not qualify if:

• Pregnancy
• Acute illness/ cognitive impairment resulting in inability to cooperate with ultrasound
• Patients that do not consent to ultrasound examination

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Canon Medical Systems, USA: collaborator
• Siemens Medical Solutions: collaborator
• Radiological Society of North America: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Liver Cirrhosis; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

* Reference standard (biopsy) was collected from medical records. Pathology slides were not re-evaluated. * Low number of patients to perform diagnostic performance analysis

Results Point of Contact

• Title: Anthony E. Samir
• Organization: Massachusetts General Hospital

asamir@mgh.harvard.edu

6176432009

Study Officials

• Anthony E. Samir, MD, MPH

  Associate Medical Director, Ultrasound Imaging Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Service Chief,Body Ultrasound Department of Radiology, Assistant Professor at Harvard Medical School

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 17, 2017
• Study Start: June 29, 2017
• Primary Completion: August 14, 2018
• Study Completion: August 30, 2018
• Last Updated: October 28, 2019
• Results First Posted: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)