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Utility of Contrast-Enhanced Sonography and Shear Wave Elastography

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ClinicalTrials.gov Identifier: NCT04614389
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Siemens Medical Solutions USA - CSG
Information provided by (Responsible Party):
Edward Grant, University of Southern California

Study Description
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Brief Summary:
Our overall hypothesis is that Contrast-enhanced ultrasound (CEUS) and Shear Wave Elastography (SWE) will allow for high diagnostic accuracy of benign and malignant thyroid nodules, which will correlate with and complement the ACR TI-RADS classification system, allowing for more accurate diagnosis of benign and malignant thyroid nodules.

Condition or disease Intervention/treatment Phase
Thyroid Nodule Other: Contrast-enhanced ultrasound Other: Shear Wave Elastography Device: Sequoia System Not Applicable

Detailed Description:
Thyroid nodules are an exceedingly common clinical entity, however, only a small percentage of nodules are malignant. Conventional ultrasound is the current standard for the initial evaluation of thyroid nodules, yet due to several overlapping characteristics between benign and malignant nodules its utility in diagnosis has been limited, leading to a high rate of negative biopsies. To overcome these challenges the American College of Radiology has proposed a Thyroid Imaging Reporting and Data System (TI-RADS) in an effort to decrease unnecessary biopsies [5]. While these efforts have shown encouraging results, further work is still needed. Contrast-enhanced ultrasound (CEUS) and Shear Wave Elastography (SWE) are two emerging non-invasive imaging techniques which have shown promising results in the evaluation of thyroid nodules. However, data is limited and how these imaging modalities could potentially compliment ACR TI-RADS is unknown.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Eligible subjects who consent for this study will undergo a SWE and CEUS evaluation of their thyroid gland at the time of their standard of care scheduled thyroid biopsy
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utility of Contrast-Enhanced Sonography and Shear Wave Elastography in Conjunction With ACR TI-RADS for the Evaluation of Thyroid Nodules
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arms and Interventions
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Arm Intervention/treatment
CEUS and SWE
CEUS & SWE
 Other: Contrast-enhanced ultrasound
Non Invasive Imaging Technique. CEUS involves the use of microbubble contrast agents and specialized imaging techniques to enhance the signal from blood, thus showing flow in macroscopic vessels as well as tissue perfusion informatio

Other: Shear Wave Elastography
Non Ivasive Imaging Technique. Shear Wave Elastography (SWE) is a recently developed technique that uses ultrasound to noninvasively assess the mechanical stiffness of tissue by measuring tissue distortion in ponse to an acoustic radiation force impulse from a focused ultrasound beam.

Device: Sequoia System
UltraSound System Cleared by FDA 510 (k) K180067


Outcome Measures
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Primary Outcome Measures :
  1. Agreement: 1) between two radiologists for visually assessed CEUS result and 2) between the radiologists reconciled visual assessment result and the gold standard result (biopsy). [ Time Frame: 8 months ]
    Kappa analysis will be used to assess the agreement between the two radiologists visual assessment result. The rating result of each radiologist will be compared to the pathological result using Kappa analysis as well.


Secondary Outcome Measures :
  1. Agreement between the statistical model predicted result using quantitative metrics from CEUS and/or SWE and the gold standard result (biopsy). [ Time Frame: 12 months ]
    Kappa analysis will be used to re-assess the agreement between the two radiologists visual assessment result. Any disagreement between the radiologists will need to be reconciled and consensus reached. The final assessment result from the radiologists will be compared to the cytology and/or surgical gold standard using anther Kappa test.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Patients over the age of 18 with one or more thyroid nodules diagnosed on conventional ultrasound within the last 6 months.
  • Patients referred for standard of care thyroid nodule biopsy, ordered at the discretion of the treating physician and/or radiologists.
  • Patients must demonstrate ability to understand and express willingness to sign a written informed consent to undergo SWE and CEUS imaging prior to their thyroid nodule biopsy.

Exclusion Criteria:

  • Patients who are pregnant, nursing, or less than 18 years of age
  • Thyroid nodules ≤1 cm
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614389


Contacts
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Contact: Rosy Diaz-Navarro 323-865-3226 rosaura.diaz@med.usc.edu
Contact: Mario Franco 213-304-1652 mario.franco@med.usc.edu

Locations
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United States, California
USC Department of Radiology Recruiting
Los Angeles, California, United States, 90033
Contact: Mario Franco    213-304-1652    Mario.Franco@med.usc.edu   
Principal Investigator: Edward Grant, MD         
Sub-Investigator: Hisham Tchelepi, MD         
Sponsors and Collaborators
University of Southern California
Siemens Medical Solutions USA - CSG
Investigators
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Principal Investigator: Edward Grant, MD University of Southern California
More Information
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Responsible Party: Edward Grant, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT04614389    
Other Study ID Numbers: HS-19-00296
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms