Utility of Contrast-Enhanced Sonography and Shear Wave Elastography

NCT04614389 | Terminated DMC FDA Device

• 1 other identifier: HS-19-00296
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (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).

  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 Outcomes (1)

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

  12 months

Study Arms (1)

CEUS and SWE

OTHER

CEUS \& SWE

Other: Contrast-enhanced ultrasound; Other: Shear Wave Elastography; Device: Sequoia System

Interventions

Contrast-enhanced ultrasound OTHER

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

CEUS and SWE

Shear Wave Elastography OTHER

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.

CEUS and SWE

Sequoia System DEVICE

UltraSound System Cleared by FDA 510 (k) K180067

CEUS and SWE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• Patients who are pregnant, nursing, or less than 18 years of age
• Thyroid nodules ≤1 cm

Sponsors & Collaborators

• University of Southern California: lead
• Siemens Medical Solutions USA - CSG: collaborator

Study Sites (1)

USC Department of Radiology

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Edward Grant, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

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: Professor

Model Details: 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

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: November 4, 2020
• Study Start: September 4, 2019
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)