Abstract

PurposeTo compare shear wave elastography (SWE) and Afirma™ gene expression classifier (GEC) for diagnosis of malignancy in thyroid nodules (TNs) with Bethesda Classification (BC) III or IV indeterminate cytology.MethodsThis preliminary single-center prospective study was approved by the Institutional Review Board. We evaluated 151 consented patients with 151 indeterminate TNs (123 BC III, 28 BC IV) on fine-needle aspiration biopsy (FNAB). B-mode ultrasound, vascularity, and SWE were performed prior to FNAB. TN stiffness was measured as shear wave velocity (SWV) in meters per second (m/s). The stiffest area of the TN was selected for SWV measurement. GEC testing was performed with a second FNAB. Surgery was recommended for GEC-suspicious TNs, or GEC-benign TNs with two or more worrisome B-mode US features.ResultsSurgical pathology confirmed 31 malignant TNs. Among the GEC-suspicious group, 28 of 59 TNs were malignant. The SWV value of ≥3.59 m/s was the best cut-off for malignancy risk based on the receiver operating curve (ROC). Twenty-six malignant TNs had SWV ≥ 3.59 m/s. The sensitivity and specificity for SWV ≥ 3.59 m/s were 83.9 and 79.2%, respectively. Positive predictive value (PPV) was 51.0% and negative predictive value (NPV) was 95.0%. For the GEC-suspicious group, sensitivity, specificity, PPV, and NPV were 90.3, 74.2, 47.5, and 96.7%, respectively. In multivariate analysis, SWV and GEC-suspicious were significant predictors of malignancy, but B-mode features and vascularity were not.ConclusionThis preliminary study indicates that SWE and GEC are independent predictors of malignancy in TNs with BC III or IV.

Highlights

  • Management of thyroid nodules (TNs) with indeterminate fine-needle aspiration biopsy (FNAB) has been a major challenge for thyroid experts

  • We previously reported that TN stiffness measured by Virtual touch imaging quantification (VTIQ)-generated shear wave elastography (SWE) is an independent predictor of thyroid cancer (TC) when TNs with all Bethesda classifications were included

  • All TNs were evaluated with a high-resolution US and FNAB

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Summary

Introduction

Management of thyroid nodules (TNs) with indeterminate fine-needle aspiration biopsy (FNAB) has been a major challenge for thyroid experts. The Bethesda System for the Reporting of Thyroid Cytopathology renders standardized reporting criteria for TN FNAB cytopathology. Bethesda categories (BC) include: I (non-diagnostic or unsatisfactory), II (benign), III (atypia of undetermined significance or follicular lesion of undetermined significance), IV (follicular neoplasm or suspicious for follicular neoplasm), V (suspicious for malignancy) or VI (malignant) [1]. Indeterminate cytology categories include BC III and BC IV. 15–30% of TN aspirations are interpreted as indeterminate, but the majority has benign surgical pathology. Among these patients, the risk for serious surgical complications ranges between 2–10% [2]

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