Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules

NCT01757834 | Unknown

• 2 other identifiers: 41443-EA1R21CA164112-01
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Shear wave ultrasound elastography is a new technique of finding the softness or hardness in tissue by applying a "push" generated by the machine. This technique will help in diagnosing malignancy in the thyroid gland without biopsy and avoiding biopsy in noncancerous nodules.

Conditions

Thyroid Nodule

Keywords

Thyroid Nodule; Thyroid Neoplasm; Differential Diagnosis; Elastography; Elasticity Imaging Technique; Sonoelastography

Outcome Measures

Primary Outcomes (1)

• Correlating stiffness from the SWUS elastography with indentometer and pathology findings

  SWUS elastography can provide an objective score of stiffness, i.e., the Elasticity Index. Stiffness from the SWUS elastography will be correlated with the elasticity measured with an indentometer to validate the Elasticity Index. The Elasticity Index will also be correlated with the histopathologic diagnosis. The sensitivity and specificity of the method for the diagnosis of malignancy will be assessed.

  Up to 2 months. A one-time SWUS elastography will be performed on Day 1 within 2 months prior to the patients scheduled clinical FNA or surgery.

Secondary Outcomes (1)

• Correlating SWUS findings with routine US findings

  Up to 2 months. A one-time SWUS elastography will be performed on Day 1 within 2 months prior to the patients scheduled clinical FNA or surgery.

Study Arms (1)

SWUS Elastography

EXPERIMENTAL

This is a noninvasive technique using focused ultrasonic beams (pushing beams.) Several pushing beams at increasing depths are transmitted to generate a quasi-plane shear wave frame that propagates throughout the imaging area. After generating the shear wave, an ultrafast imaging sequence is performed to acquire successive raw radiofrequency dots at a very high frame rate (up to 20,000 per second). A tissue elasticity assessment can be derived from shear wave propagation speed. A color-coded image is displayed; softer tissue in blue and stiffer tissue in red. Quantitative information is delivered by drawing regions of interest on the thyroid and surrounding tissues which is the Elasticity Index expressed in kilo-Pascal (kPa). Due to the lack of manual compression and known value of the strength of pushing beam, SWUS gives an objective number to stiffness within the nodule.

Device: SWUS Elastography

Interventions

SWUS Elastography DEVICE

Also known as: Aixplorer Ultrasound System (SuperSonic Imagine, Inc)

SWUS Elastography

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of thyroid nodule
• Referred for thyroid FNA or surgery

You may not qualify if:

• Minors; age \<18
• Unable to provide informed consent

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Manjiri K. Dighe, MD

  University of Washington

  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: Associate Professor of Radiology

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 31, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)