Assessing Indeterminate Thyroid Nodules With Electrical Impedance Measurements

描述（由申请人提供）：甲状腺结节存在于大部分健康个体中。4% - 7%的美国成年人有可触及的甲状腺结节，50岁以上的美国女性中有高达50%的人有可在超声上显示的结节。绝大多数（约95%）甲状腺结节是良性的。然而，随着男性性别、结节大小、极端年龄（< 30岁和60岁以下）、潜在的自身免疫性疾病、结节生长、个人或甲状腺癌家族史以及辐射暴露，癌症风险增加。超声成像和细针穿刺活检（FNAB）仍然是甲状腺结节评估的主要手段。不幸的是，25%最终接受甲状腺结节FNAB的患者细胞学不确定。这些患者中的许多人至少需要部分甲状腺切除术，纯粹是为了获得明确的诊断。考虑到其中只有30%最终在外科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是可以避免的。电阻抗扫描（EIS）以前被研究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，称为共振电阻抗谱（REIS），对于这一目的应该具有更高的灵敏度和特异性。当使用REIS技术检查乳房时，我们获得的初步结果在各方面都明显优于传统的EIS。我们相信REIS技术将同样改善甲状腺结节的评估。REIS有望成为许多不确定甲状腺结节患者风险分层的可重复模式。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。本申请的目的是设计、组装并在初步临床研究中测试一种独特的基于REIS的甲状腺结节评估设备。

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.