Utility of Contrast-Enhanced Sonography and Shear Wave Elastography

Not Applicable

Terminated

• Conditions: Thyroid Nodule
• Interventions: Other: Contrast-enhanced ultrasound; Other: Shear Wave Elastography; Device: Sequoia System

• Registration Number: NCT04614389
• Lead Sponsor: University of Southern California

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.

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 Timeline

• Study Start: 2019-09-04
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-04
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CEUS and SWE	Shear Wave Elastography	CEUS \& SWE
CEUS and SWE	Sequoia System	CEUS \& SWE
CEUS and SWE	Contrast-enhanced ultrasound	CEUS \& SWE

Primary Outcome Measures

Name	Time	Method
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).	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

Name	Time	Method
Agreement between the statistical model predicted result using quantitative metrics from CEUS and/or SWE and the gold standard result (biopsy).	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.

Trial Locations

Locations (1)

USC Department of Radiology; 🇺🇸 Los Angeles, California, United States