Regional Variation of FDG-PET Scans to diagnose lung cancer

描述（由申请人提供）：肺癌每年导致超过16万人死亡，超过乳腺癌、前列腺癌、肾癌、结肠癌、肝癌和皮肤癌的总和。由于计算机断层扫描（CT）扫描次数的增加，发现了更多可疑的肺结节。F18-氟脱氧葡萄糖正电子发射断层扫描（FDG-PET）由医疗保险和医疗补助服务中心（CMS）批准用于诊断可疑肺结节，是目前临床医生可用的最准确的非侵入性诊断工具。肺癌通常代谢活跃，导致PET扫描上可见FDG亲合性病变。活动性感染也可能是代谢活跃的（FDG avid），导致假阳性结果。回顾性单机构研究已经证明，感染性真菌性肺部疾病，如组织胞浆菌病，降低了FDG-PET扫描诊断肺癌的特异性。真菌性肺病是一种以土壤为基础的有机体，在美国中部很常见。在该国真菌性肺病发病率高的地区，假阳性FDG-PET扫描导致20%至30%的病例进行不必要的肺部手术来诊断肺癌。这些手术的死亡率为1-2%。准确和非侵入性诊断肺癌的能力受到不知道FDG-PET表现不佳的国家的情况和地区的限制。了解FDG-PET扫描准确性的区域差异将有助于成本效益研究，改善预测模型，并帮助临床医生更准确地诊断肺癌。美国外科医师学会肿瘤组（ACOSOG）Z4031国家合作研究（5 U10 CA 076001 -11）于2006年完成，入组了1000多例已知或疑似肺癌患者。该研究的目的是评估肺癌的血清血液检测。影像报告和临床数据已由经过培训的评审员提取到数据库中，超过1000名患者和超过665名患者有FDG-PET扫描结果。ACOSOG数据集为研究FDG-PET的影响提供了理想的来源。我们研究的目的是检验FDG-PET诊断肺癌的区域准确性存在的假设，并确定该测试是否适用于真菌性肺病流行率高的地区。在目标1中，我们将检查FDG-PET扫描测试在诊断肺癌方面的特征是否因机构和/或地理区域而异。这一目标将根据入组机构确定特异性的变化， 与地方性组织胞浆菌病发病率的关系。在目标2中，我们将使用个体患者的邮政编码作为定位器，并检查ACOSOG Z4031研究中的假阳性FDG-PET扫描是否在地方性真菌病地区与真菌病低负担地区相比有所增加。目标2的主要可交付成果将使用逻辑回归来检查诊断肺癌的假阳性FDG-PET扫描与地方性组织胞浆菌病发病率之间是否存在关联。

DESCRIPTION (provided by applicant): Lung cancer kills over 160,000 people annually, more people than breast, prostate, kidney, colon, liver and skin cancer combined. More suspicious lung nodules are being found due to increased numbers of Computed Tomography (CT) scans being performed. F18-Fluorodeoxyglucose Positron Emission Tomography (FDG- PET) is approved by Centers for Medicare and Medicaid Services (CMS) for diagnosing suspicious lung nodules and is currently the most accurate non-invasive diagnostic tool available to clinicians. Lung cancer is typically metabolically active resulting in an FDG avid lesion seen on the PET scan. Active infections may also be metabolically active (FDG avid) resulting in false positive results. Retrospective single institution studies have demonstrated that infectious fungal lung diseases, such as histoplasmosis, reduce the specificity FDG- PET scans to diagnose lung cancer. Fungal lung disease is a soil based organism and common in the central Unites States. In regions of the country with high rates of fungal lung disease, false positive FDG-PET scans result in unnecessary lung operations being performed to diagnose lung cancer in 20 to 30 percent of cases. These operations have a 1-2% mortality rate. The ability to accurately and non-invasively diagnose lung cancer is limited by not knowing the circumstances and regions of the country that FDG-PET performs poorly. Understanding the regional variation of FDG-PET scan accuracy will aid cost-effectiveness studies, improve predictive models and help clinicians more accurately diagnose lung cancer. The American College of Surgeons Oncology Group (ACOSOG) Z4031 national cooperative study (5U10CA076001-11) was completed in 2006 and enrolled over 1000 patients with known or suspected lung cancer. The purpose of that study was to evaluate a serum blood test for lung cancer. Imaging reports and clinical data have been extracted into a database by trained reviewers for over 1000 patients and over 665 patients have FDG-PET scan results. The ACOSOG dataset provides an ideal source to examine the impact of FDG-PET. The purpose of our study is to test the hypothesis that regional accuracy of FDG-PET to diagnose lung cancer exists and determine if this test is useful in areas where there are high endemic rates of fungal lung disease. In aim 1 we will examine whether FDG-PET scan test characteristics in diagnosing lung cancer vary by institution and/or geographic region. This aim will determine the variation in specificity based on the enrolling institution and the relationship to the endemic histoplasmosis rate. In aim 2 we will use individual patient zip codes as a locator and examine whether false positive FDG-PET scans in the ACOSOG Z4031 study are increased in areas with endemic fungal disease compared to areas of with a low burden of fungal disease. The primary deliverable for aim 2 will use logistic regression to examine if an association exists between false positive FDG-PET scans to diagnose lung cancer and endemic histoplasmosis rates.