Clinical trial NCT01757834: Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
Official title: Efficacy of Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Keywords: Thyroid Nodule
Thyroid Neoplasm
Differential Diagnosis
Elastography
Elasticity Imaging Technique
Sonoelastography
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-12-31
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Correlating stiffness from the SWUS elastography with indentometer and pathology findings
timeFrame: 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:
measure: Correlating SWUS findings with routine US findings
timeFrame: 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.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Manjiri K. Dighe, MD
role: PRINCIPAL_INVESTIGATOR
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