Regional Variation of FDG-PET Scans to diagnose lung cancer

描述（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）扫描的增加，越来越多的可疑肺结节被发现。f18 -氟脱氧葡萄糖正电子发射断层扫描（FDG- PET）被医疗保险和医疗补助服务中心（CMS）批准用于诊断可疑的肺结节，是目前临床医生可用的最准确的非侵入性诊断工具。肺癌典型的代谢活跃导致PET扫描上可见FDG强烈病变。活动性感染也可能是代谢活跃（FDG avid）导致假阳性结果。回顾性单机构研究表明，肺部感染性真菌疾病，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。在该国真菌肺病发病率高的地区，FDG-PET扫描假阳性导致20%至30%的病例进行不必要的肺部手术，以诊断肺癌。这些手术的死亡率为1-2%。由于不了解FDG-PET表现不佳的国家的情况和地区，准确和非侵入性诊断肺癌的能力受到限制。了解FDG-PET扫描准确度的区域差异将有助于成本效益研究，改进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（5U10CA076001-11）于2006年完成，纳入了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测试。超过1000名患者的影像学报告和临床数据已被训练有素的审查员提取到数据库中，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。我们研究的目的是验证FDG-PET诊断肺癌的区域准确性的假设，并确定该测试是否在真菌肺病高发地区有用。在目的1中，我们将研究FDG-PET扫描诊断肺癌的特征是否因机构和/或地理区域而异。这一目标将根据招收机构和学生的具体情况而定

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. PUBLIC HEALTH RELEVANCE: FDG-PET scan (F18-Fluorodeoxyglucose Positron Emission Tomography) is among the most accurate non- invasive test for diagnosing lung cancer. However, populations and regions of the country may exist where FDG-PET scans does not help in diagnosing lung cancer compared to computed tomography scans alone due to high numbers of false positive results from fungal lung disease such as histoplasmosis. This proposal will estimate FDG-PET's geographic variation of diagnostic accuracy in the United States and southern Canada using existing data from a completed national lung cancer trial.