Utility of Contrast-Enhanced Sonography and Shear Wave Elastography

Utility of Contrast-Enhanced Sonography and Shear Wave Elastography in Conjunction With ACR TI-RADS for the Evaluation of Thyroid Nodules

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.

Study Overview

• Status: Terminated
• Conditions: Thyroid Nodule
• Intervention / Treatment: Other: Contrast-enhanced ultrasound; Other: Shear Wave Elastography; Device: Sequoia System

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Department of Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between the statistical model predicted result using quantitative metrics from CEUS and/or SWE and the gold standard result (biopsy).	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.	12 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Siemens Medical Solutions USA - CSG
• Investigators: Principal Investigator: Edward Grant, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: HS-19-00296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No