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Efficacy of Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroi

剪切波超声弹性成像在甲状腺无创诊断中的疗效

基本信息

批准号：
8534062
负责人：
Manjiri Dighe
金额：
$ 15.49万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-20 至 2015-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8534062
关键词：
Accounting Adult Area Benign Binding Biopsy Characteristics Clinical Clinical Research Clinical Trials Color Cytopathology Databases Diagnosis Diagnostic Diagnostic Procedure Diagnostic tests Enrollment Evaluation Fine needle aspiration biopsy Future Generations Goals Hardness Health Care Costs Histopathology Incidence Lead Lesion Malignant - descriptor Malignant Neoplasms Manuals Measurement Measures Medical Medicare Methods Multicenter Studies Nature Nodular Goiter Nodule Operative Surgical Procedures Palpable Papillary Carcinoma Pathology Patients Performance Population Procedures Process Radiation Research Resected Resources Sampling Shear Strength Specificity Techniques Thyroid Diseases Thyroid Gland Thyroid Nodule Tissues Triage Ultrasonic wave Ultrasonics Ultrasonography United States Work base clinical practice cost design elastography experience health care service utilization imaging modality improved insight neoplastic noninvasive diagnosis operation prospective screening tool

项目摘要

DESCRIPTION (provided by applicant): 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. FNA procedure for a single thyroid nodule costs $624, while an US exam of the thyroid gland costs $233 per Seattle area estimated Medicare Reimbursement Rates. If a patient undergoes an US exam and an FNA procedure on the suspicious lesion, the average cost for thyroid nodule evaluation exceeds $800. Since the yearly incidence of thyroid nodules in the USA population is about 232,000 to 282,000, approximately $225 Million is spent every year to diagnose benign nodules. Thus, to diagnose every malignant nodule, more than $12,000 ($225M/18,000 malignant nodules detected) is spent to detect and exclude the benign nodules. In addition, the invasive nature of the procedure tends to take a toll on the patients, both psychologically and emotionally. 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. We 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. We 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. We 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.

描述（由申请人提供）：甲状腺结节是一种常见的医疗问题。随着各种成像方式的广泛使用，偶然发现甲状腺结节变得越来越常见。然而，这些结节中的大多数是良性的，只有5-10%的一小部分是恶性的。随着检测到的结节数量的增加，这些甲状腺结节的评价提出了诊断挑战，因为目前用于评价的成像模式，即单独的超声（US）具有约50- 70%的低特异性。为了提高特异性，以确信地诊断甲状腺结节中的恶性肿瘤，进行细针穿刺（FNA）活检。一个甲状腺结节的FNA手术费用为624美元，而美国甲状腺检查的费用为每西雅图地区233美元。如果患者在可疑病变上接受US检查和FNA程序，甲状腺结节评估的平均费用超过800美元。由于美国人口甲状腺结节的年发病率约为232，000至282，000，每年约花费2.25亿美元用于诊断良性结节。因此，为了诊断每一个恶性结节，花费超过12，000美元（2.25亿美元/检测到的18，000个恶性结节）来检测和排除良性结节。此外，手术的侵入性往往会在心理和情感上对患者造成伤害。近年来，在各种研究中，超声弹性成像在区分良性和恶性结节方面具有90 - 98%的高特异性。US弹性成像的工作原理是通过施加压缩（可以是手动压缩）或通过聚焦超声束（称为剪切波）产生远程辐射力来检测组织内的硬度。剪切波超声（SWUS）弹性成像是一种客观的超声弹性成像方法，可检测结节内的硬度，因为所产生的剪切波强度是已知的，并且可以控制。SWUS弹性成像在以前涉及术前患者的研究中显示出能够非侵入性诊断乳头状癌的前景。我们建议进行一项研究，以探讨SWUS弹性成像在诊断恶性甲状腺结节和无创减少FNA的数量，避免FNA在良性结节的有效性。我们将在甲状腺结节患者接受FNA活检或手术前招募他们。我们还建议比较常规超声和SWUS弹性成像及其联合使用在区分恶性和良性结节。我们假设SWUS弹性成像可以作为一种非侵入性的筛查工具，在FNA之前，以高置信度筛选出良性和恶性结节，并减少未来活检的数量。