FDG-PET Imaging in painful Hip Prosthesis

描述(申请人提供)：美国每年大约进行200,000例髋关节置换手术。尽管由于采取了某些预防措施，髋关节置换术后急性感染的发生率有所降低，但早期和晚期感染仍然是发病率、死亡率和巨额费用的重要来源。据估计，受感染的关节置换的治疗费用在每个患者50,000至60,000美元之间。确定感染的诊断是相当困难的，所遇到的发病率和费用很大程度上是由于在管理疼痛的全髋关节假体患者时缺乏一种高度准确且经济有效的单一测试。目前的诊断测试，包括常规放射照相、实验室研究和核医学程序，都存在着严重的缺陷，包括准确性和成本。已有研究表明，[18-F]氟脱氧葡萄糖(FDG)和正电子发射断层扫描(PET)显示炎症部位具有很高的敏感性和特异性。在我们机构进行的一项初步研究中，我们已经能够证明FDG-PET成像在相对较少的患者群体中设置疼痛全髋关节假体具有很高的准确性。这项拟议的研究的主要目标是确定FDG-PET成像在管理大量患者群体中疼痛的全髋关节假体方面的有效性。我们还打算将FDG-PET成像与包括放射性标记白细胞成像在内的诊断髋关节感染的常规技术进行直接比较，以确定FDG-PET成像是否优于现有技术。此外，我们还将优化诊断髋关节假体相关感染的FDG-PET成像标准。我们计划在5年内招募530名患者，以实现申请中概述的目的。通过实施建议的研究，我们将能够证明这项技术在疼痛髋关节置换术患者管理中的有效性。我们相信，这项前景看好的技术在准确诊断这一严重而具有挑战性的临床问题方面具有巨大的潜力，并可能对这些患者的预后产生重大影响。

DESCRIPTION (provided by applicant): Approximately 200,000 total hip replacements are performed in the U.S. each year. Although the incidence of acute infection following hip replacement is reduced as certain preventative measures have been adopted, both early and late infections remain as significant sources of morbidity, mortality and substantial expenses. The treatment of infected joint replacements has been estimated to cost between $50,000-60,000 per patient. Establishing the diagnosis of infection is quite difficult, and much of the morbidity and cost encountered is due to the lack of a single test that is highly accurate, and cost effective in the management of patients with painful total hip prosthesis. Current diagnostic tests including routine radiography, laboratory studies, and nuclear medicine procedures, suffer from significant shortcomings including accuracy and cost. It has been shown that [ 18-F] fluorine deoxyglucose (FDG) and Positron Emission Tomography (PET) reveal sites of inflammation with high sensitivity and specificity. In a pilot study conducted at our institution, we have been able to demonstrate that FDG-PET imaging has high accuracy in the setting of painful total hip prosthesis in a relatively small patient population. The main objective of the proposed research study is to determine the efficacy of FDG-PET imaging in the management of a painful total hip prosthesis in a large patient population. We also intend to compare FDG-PET imaging directly to conventional techniques including radio labeled white cell imaging for the diagnosis of hip infection to determine whether FDG-PET imaging is superior to the existing techniques. Furthermore, we will optimize the FDG-PET imaging criteria for diagnosing infection associated with hip prosthesis. We plan to enroll 530 patients over 5 years for the purposes outlined in the application. By implementing the proposed research, we will be able to demonstrate the effectiveness of this technique in the management of patients with painful hip arthroplasty. We believe this promising technology has great potential for the accurate diagnosis of this serious and challenging clinical problem, and may substantially influence the outcome in these patients.