FDG-PET/CT in the evaluation of persistent febrile neutropenia in cancer patients

FDG-PET/CT 评估癌症患者持续性发热性中性粒细胞减少症

• 批准号: 7415090
• 负责人: John M Hoffman
• 金额: $ 28.41万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7415090
• 关键词: Accounting; Address; Adverse effects; Anatomic Sites; Anatomy; Anti-Bacterial Agents; Antibiotic Therapy; Antibiotics; Antifungal Agents; Applications Grants; Area; Bacteria; Biopsy; Cancer Patient; Cardiac; Caring; Cell Count; Cells; Cessation of life; Clinical; Clinical Trials Design; Communicable Diseases; Complication; Condition; Cost Savings; Count; Data; Dementia; Deoxyglucose; Detection; Development; Diagnostic Neoplasm Staging; Diagnostic radiologic examination; Elements; Endotoxins; Evaluation; Fever; Fever of Unknown Origin; Glucose; Goals; Hexoses; Hospitalization; Hospitals; Image; Infection; Inflammation; Inflammatory; Insurance Carriers; Interruption; Knowledge; Label; Lead; Leukocytes; Life; Literature; Localized; Malignant Neoplasms; Measures; Medical Care Costs; Methods; Modality; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Nature; Neutropenia; Numbers; Oncologist; PET/CT scan; Pathologic; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pilot Projects; Population; Publishing; Quality of life; Radiopharmaceuticals; Range; Reaction; Reporting; Resistance; Resolution; Risk; Safety; Scanning; Score; Site; Source; System; Therapeutic; Therapy Evaluation; Tissues; Toxic effect; Tracer; Translating; Translations; Upper arm; Viral; Week; cancer therapy; chemotherapy; clinical application; concept; cost; cost effectiveness; day; design; fungus; glucose analog; glucose uptake; improved; mortality; neoplastic cell; neutrophil; novel; oncology; prospective; response; uptake

DESCRIPTION (provided by applicant): Although there have been many advances in the assessment and treatment of infections responsible for febrile neutropenia in cancer patients, it still remains a common complication of cancer therapy and accounts for the majority of chemotherapy-associated deaths. The ultimate goal of our interdisciplinary group of oncologists, infectious diseases experts, imagers, and biostatisticians is to conduct a large, prospective, multi-center trial to establish the utility and cost-effectiveness of PET/CT using the widely available glucose analogue [18F]fluoro-2-deoxy- D-glucose (FDG) in identifying sites of infection in cancer patients with persistent febrile neutropenia without an obvious identifiable source thus improving targeted therapy. The immediate goal of this Quick-Trials Exploratory Grant application is to conduct a pilot project in a smaller group of these patients to provide critical information that will support the concept, and aid in the design, of a larger multi-center clinical trial. The primary aim of this exploratory study is to perform FDG-PET/CT in approximately 130 cancer patients with persistent febrile neutropenia in whom an obvious source of infection has not been identified. Each suspicious site will be confirmed with pathologic ground truth whenever possible. The data will be evaluated to address the following questions, which are the sub-aims of this proposal: 1. How effective is FDG-PET/CT in identifying sites of infection in cancer patients with persistent febrile neutropenia without an obvious cause? 2. To what degree does FDG-PET/CT improve detection of sites of infection over CT alone? 3. What FDG-PET/CT imaging variables best predict the presence of infection at a specific site (e.g. standardized uptake value [SUV], concomitant abnormality on CT)? 4. Can the magnitude of FDG uptake as measured by an SUV at sites of infection predict the identity of the infective agent (bacterial vs. fungal vs. viral)? 5. Does the magnitude of uptake at sites of infection correlate with absolute neutrophil count? 6. Can a clinical scoring system be developed to identify a population of patients in whom FDG-PET/CT is likely to be most efficacious in identifying sites of infection? It is possible that FDG-PET/CT may be able to significantly change the management of the cancer patient with persistent febrile neutropenia resulting in improved clinical care; decrease the morbidity due to toxicities from certain toxic antibiotics; potentially decrease the cost of medical care by improved targeting of antibiotic therapy; and decrease days of hospitalization for these patients. All of these potential benefits may result in significant cost savings. FDG-PET/CT may be able to significantly change the management of cancer patients with persistent febrile neutropenia. FDG-PET/CT may be the most appropriate way to localize sources of occult and potentially life-threatening infections thus directly impacting therapy which may significantly impact the quality of life of very ill cancer patients by reducing morbidity and mortality.

描述（由申请人提供）：尽管在癌症患者中引起发热性中性粒细胞减少症的感染的评估和治疗方面取得了许多进展，但它仍然是癌症治疗的常见并发症，并且是化疗相关死亡的主要原因。我们由肿瘤学家、传染病专家、成像师和生物统计学家组成的跨学科小组的最终目标是进行一项大型、前瞻性、多中心试验，以使用广泛使用的葡萄糖类似物来确定 PET/CT 的实用性和成本效益 [18F ]氟-2-脱氧-D-葡萄糖（FDG）可用于识别患有持续性发热性中性粒细胞减少症但没有明显可识别来源的癌症患者的感染部位，从而改善靶向治疗。这项快速试验探索性资助申请的直接目标是在一小部分患者中开展试点项目，以提供支持更大的多中心临床试验概念并帮助设计的关键信息。这项探索性研究的主要目的是对大约 130 名患有持续性发热性中性粒细胞减少症的癌症患者进行 FDG-PET/CT，这些患者的明显感染源尚未确定。只要有可能，每个可疑部位都将通过病理基础事实进行确认。将评估数据以解决以下问题，这些问题是本提案的子目标： 1. FDG-PET/CT 在识别无明显原因的持续性发热性中性粒细胞减少症癌症患者的感染部位方面有多有效？ 2. 与单独使用 CT 相比，FDG-PET/CT 在多大程度上改善了感染部位的检测？ 3. 哪些 FDG-PET/CT 成像变量最能预测特定部位是否存在感染（例如标准化摄取值 [SUV]、CT 上伴随的异常）？ 4. 通过 SUV 在感染部位测量的 FDG 摄取量能否预测感染源的身份（细菌、真菌、病毒）？ 5. 感染部位的摄取量与中性粒细胞绝对计数相关吗？ 6. 是否可以开发一个临床评分系统来识别 FDG-PET/CT 在识别感染部位方面可能最有效的患者群体？ FDG-PET/CT 可能能够显着改变患有持续性发热性中性粒细胞减少症的癌症患者的治疗，从而改善临床护理；降低某些有毒抗生素的毒性引起的发病率；通过改善抗生素治疗的针对性，可能降低医疗费用；并减少这些患者的住院天数。所有这些潜在的好处都可能带来显着的成本节省。 FDG-PET/CT 可能能够显着改变患有持续性发热性中性粒细胞减少症的癌症患者的治疗。 FDG-PET/CT 可能是定位隐匿性和潜在危及生命的感染源的最合适方法，从而直接影响治疗，从而降低发病率和死亡率，从而显着影响重病癌症患者的生活质量。