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Efficacy of Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules

18 Years
Open (Enrolling by invite only)
Thyroid Nodule

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Trial Information

Efficacy of Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules

Thyroid nodules are a common medical problem. With the wide use of various imaging
modalities, incidentally detected thyroid nodules are becoming more common. However most of
these nodules are benign with only a small proportion of 5-10% being malignant. With the
increasing number of nodules detected, evaluation of these thyroid nodules presents a
diagnostic challenge since the imaging modality used for evaluation at present, i.e.,
ultrasound (US) alone, has a low specificity of approximately 50-70%. In order to improve
specificity to confidently diagnose malignancy in the thyroid nodule, a fine needle
aspiration (FNA) biopsy is performed.

In recent years, US elastography has been shown to have high specificity of 90- 98% in
various studies in differentiating between benign and malignant nodules. US elastography
works on the principle of detecting the stiffness within a tissue by applying compression
which can be manual compression or by generation of a remote radiation force by focused
ultrasonic beams called as shear waves. Shear Wave Ultrasound (SWUS) elastography is an
objective method of US elastography that detects the stiffness within the nodule since the
strength of the shear wave generated is known and can be controlled. SWUS elastography has
shown promise in being able to noninvasively diagnose papillary carcinoma in previous
studies involving preoperative patients.

The investigators propose to perform a study to investigate the efficacy of SWUS
elastography in diagnosing malignant thyroid nodules and noninvasively decreasing the number
of FNAs performed by avoiding FNA in benign nodules. The Investigators will enroll patients
with thyroid nodules before they undergo FNA biopsy or surgery. We also propose to compare
routine US and SWUS elastography and their combined use in differentiating malignant from
benign nodules. The investigators hypothesize that SWUS elastography can be used as a
noninvasive screening tool, prior to an FNA, to screen out benign and malignant nodules with
high level of confidence and reduce the number of biopsies in the future.

Inclusion Criteria:

- Clinical diagnosis of thyroid nodule

- Referred for thyroid FNA or surgery

Exclusion Criteria:

- Minors; age <18

- Unable to provide informed consent

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Correlating stiffness from the SWUS elastography with indentometer and pathology findings

Outcome Description:

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.

Outcome Time Frame:

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.

Safety Issue:


Principal Investigator

Manjiri K. Dighe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Institutional Review Board

Study ID:




Start Date:

November 2012

Completion Date:

February 2014

Related Keywords:

  • Thyroid Nodule
  • Thyroid Nodule
  • Thyroid Neoplasm
  • Differential Diagnosis
  • Elastography
  • Elasticity Imaging Technique
  • Sonoelastography
  • Thyroid Diseases
  • Thyroid Nodule



University of Washington Medical CenterSeattle, Washington  98195-6043