Assessing Indeterminate Thyroid Nodules With Electrical Impedance Measurements

描述(申请人提供)：甲状腺结节存在于很大一部分健康个体中。美国成年人口中有4%到7%的人有明显的甲状腺结节，50岁以上的美国妇女中有多达50%的人有可以在超声波上显示的结节。绝大多数(95%)的甲状腺结节是良性的。然而，癌症风险随着男性性别、结节大小、极端年龄(30岁和60岁)、潜在的自身免疫性疾病、结节生长、甲状腺癌个人或家族病史以及辐射暴露而增加。超声成像和细针吸取活检(FNAB)仍然是评估甲状腺结节的主要方法。不幸的是，最终接受甲状腺结节FNAB的患者中，有25%的患者细胞学不确定。其中许多患者将需要至少部分切除甲状腺，纯粹是为了获得明确的诊断。鉴于其中只有30%的结节最终在手术病理上被证明是恶性的，如果有更好的非侵入性方法来评估不确定的结节，这些肺叶切除术中的大多数可能是可以避免的。电阻抗扫描(EIS)已被用于甲状腺结节的非侵入性评估。EIS的总体诊断准确性令人鼓舞，但不足以用于常规临床应用。我们已经开发了一种改进的方法，称为共振阻抗谱(REIS)，对于这一目的应该具有更高的灵敏度和特异度。当使用REIS技术检查乳房时，我们获得了在所有方面都明显好于传统EIS的初步结果。我们相信，REIS技术同样将改善对甲状腺结节的评估。REIS有望作为一种可重复的方法，对许多不确定的甲状腺结节患者进行风险分层。这是一种新的非侵入性方式，可能有助于减少诊断性肺叶切除术的数量，并将受到非诊断性FNA结果患者的欢迎。这项应用的目的是设计、组装并在初步临床研究中测试一种独特的基于REIS的设备，用于评估甲状腺结节。 公共卫生相关性：我们建议设计、组装并在技术和初步人体研究中测试一种非侵入性、易于使用的设备，用于测量FNA不确定甲状腺结节的共振阻抗谱(REIS)。我们将评估这项技术在“诊断性”手术前准确地将这些不确定的结节定性为良性或恶性的能力。

DESCRIPTION (provided by applicant): Thyroid nodules are present in a large fraction of healthy individuals. Between 4% and 7% of the United States adult population has palpable thyroid nodules, and up to 50% of American women older than age 50 have nodules that can be depicted on ultrasound. The vast majority (>95%) of thyroid nodules are benign. However, cancer risk increases with male gender, nodule size, extremes of age (< 30 and > 60 years), underlying autoimmune disease, nodule growth, personal or family history of thyroid cancer, and radiation exposure. Ultrasound imaging and Fine Needle Aspiration Biopsy (FNAB) remain the mainstays of thyroid nodule evaluation. Unfortunately, 25% of patients who ultimately undergo FNAB of a thyroid nodule have indeterminate cytology. Many of these patients will require at least partial thyroidectomy purely for the purpose of obtaining a definitive diagnosis. Given that only 30% of these will ultimately prove to be malignant on surgical pathology, the majority of these lobectomies could potentially be avoided if better non-invasive methods existed to evaluate indeterminate nodules. Electrical Impedance Scanning (EIS) has been previously investigated for non-invasive evaluation of thyroid nodules. The overall diagnostic accuracy of EIS was encouraging but not sufficient for routine clinical use. We have developed a modified approach termed here Resonance Electrical Impedance Spectroscopy (REIS) that should have substantially higher sensitivity and specificity for this very purpose. When using REIS technology to examine the breast, we obtained initial results that are significantly better in all respects than those obtained with traditional EIS. We believe that REIS technology will similarly improve the assessment of thyroid nodules. REIS hold promise as a reproducible modality for the risk stratification of the many patients with indeterminate thyroid nodules. It is a new non- invasive modality that may help reduce the number of diagnostic lobectomies and would be welcomed by patients with non-diagnostic FNA results. The purpose of this application is to design, assemble, and test in a preliminary clinical study a unique REIS based device for the assessment of thyroid nodules. PUBLIC HEALTH RELEVANCE: We propose to design, assemble, and test in technical and preliminary human studies a non-invasive, easy to use device for measuring Resonance Electrical Impedance Spectroscopy (REIS) of FNA indeterminate thyroid nodules. We will assess the ability of this technology to accurately characterize these indeterminate nodules as benign or malignant prior to a "diagnostic" surgery.