Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid

Study Overview
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Brief Summary
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As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery. Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery for diagnosis of a benign lesion. The aim of this study is to see whether shear-wave elastography, a new ultrasound technology can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients will not need surgery for the diagnosis of a benign lesion. The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and are scheduled for thyroid surgery will be eligible to participate. All participants will undergo a detailed ultrasound examination prior to their surgery. The results of the ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy of SWE.

Official Title
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A Multivariate Analysis of Factors Predictive of Carcinoma in Follicular Neoplasms of the Thyroid Gland

Conditions
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Thyroid Nodule, Follicular Neoplasm

Intervention / Treatment
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* Device: Shear-Wave Elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with a Follicular Neoplasm on fine needle aspiration biopsy Patients >18 years of age Exclusion Criteria None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shear-Wave Elastography<br>Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. | Device: Shear-Wave Elastography<br>* Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.<br>* Other names: Supersonic Aixplorer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) | Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery. | Baseline (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid, Follicular Neoplasms, Bethesda System, Elastography, Doppler ultrasound, Thyroidectomy