FDG-PET Imaging in Complicated Diabetic Foot

描述（由申请人提供）：1100万美国糖尿病患者中约有25%患有周围神经病变，糖尿病相关足部并发症占下肢非创伤性截肢的大部分。在这个人群中，骨髓炎和足部深部感染是相对常见的并发症。这些并发症的早期诊断对这些患者的治疗至关重要，因为及时的抗生素治疗可以治愈感染，因此可以降低截肢率。然而，在这种情况下，由于周围血管疾病、蜂窝组织炎、神经病变和骨关节病变等并发疾病，使骨髓炎的临床表现模糊不清，因此建立骨髓炎的诊断是相当困难的。许多截肢是由于缺乏一种对骨髓炎的早期诊断具有高度敏感性、特异性和成本效益的单一测试。目前的诊断测试，包括常规放射照相、实验室研究、核医学程序和磁共振成像（MRI），存在着诸如准确性和成本不足等重大缺陷。研究表明，[18F]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灵敏度和准确性。在我们机构进行的试点研究中，我们已经能够证明FDG-PET成像在一小部分患者群体中诊断骨科感染具有很高的准确性。本研究的主要目的是确定FDG-PET成像在大量糖尿病足患者中诊断骨髓炎或深部感染的功效。我们还打算将FDG-PET成像直接与MRI进行比较，以确定FDG-PET成像是否优于这种常用技术。我们还将研究一种新型磁共振（MR）技术（由我们的一位研究者开发）在检测骨髓水肿和骨质流失方面的潜在效用。我们计划在4年内招募240名患者，用于申请中概述的目的。通过利用所提出的工作，我们将能够证明该技术在糖尿病足患者管理中的敏感性、特异性和有效性。我们相信这项有前景的技术在准确诊断这一严重且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 25 percent of the 11 million Americans with diabetes suffer from peripheral neuropathy and diabetic related foot complications account for the majority of nontraumatic amputations of the lower extremity. In this population, osteomyelitis and deep infection of the foot are relatively common complications. Early diagnosis of these complications is crucial in the management of these patients, because prompt antibiotic treatment cure infection and therefore can decrease the rate of amputation. However, establishing the diagnosis of osteomyelitis is quite difficult in this setting because of concurrent conditions, such as peripheral vascular disease, cellulitis, neuropathy and osteoarthropathy, which can obscure the clinical manifestations of osteomyelitis. Much of the amputations are due to the lack of a single test that is highly sensitive, specific and cost effective in the early diagnosis of osteomyelitis. Current diagnostic tests including routine radiography, laboratory studies, nuclear medicine procedures, and magnetic resonance imaging (MRI) suffer from significant shortcomings such as inadequate accuracy and cost. It has been shown that [18F] fluorine deoxyglucose (FDG) and Positron Emission Tomography (PET) reveal sites of inflammation with high sensitivity and accuracy. In the pilot study conducted at our institution, we have been able to demonstrate that FDG-PET imaging has high accuracy in the diagnosis of orthopedic infection in a small patient population. The main objective of the proposed research study is to determine the efficacy of FDG-PET imaging in the diagnosis of osteomyelitis or deep infection in patients with diabetic foot in a large patient population. We also intend to compare FDG-PET imaging directly to MRI to determine whether FDG-PET imaging is superior to this commonly used technique. We will also examine the potential utility of a novel magnetic resonance (MR) technique (developed by one of our investigators) in detecting marrow edema and bone loss as a result of such complications. We plan to enroll 240 patients over four years for the purposes outlined in the application. By utilization of the proposed work, we will be able to demonstrate the sensitivity, specificity, and effectiveness of this technique in the management of patients with diabetic foot. 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.