Clinical trial NCT04614389: Utility of Contrast-Enhanced Sonography and Shear Wave Elastography
Official title: Utility of Contrast-Enhanced Sonography and Shear Wave Elastography in Conjunction With ACR TI-RADS for the Evaluation of Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions USA - CSG
First posted: 2020-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: 8 months
Secondary outcomes:
measure: Agreement between the statistical model predicted result using quantitative metrics from CEUS and/or SWE and the gold standard result (biopsy).
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Department of Radiology
state: California
Study officials:
affiliation: University of Southern California
name: Edward Grant, MD
role: PRINCIPAL_INVESTIGATOR
References: