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）：尽管评估和治疗导致癌症患者发热性中性粒细胞减少症的感染和治疗取得了很多进展，但它仍然是癌症治疗的常见并发症，并且是化学疗法相关的大多数死亡。我们跨学科的肿瘤学家，感染性疾病专家，成像师和生物统计学家的最终目标是进行大型，前瞻性的多中心试验，以建立PET/CT使用广泛可用的葡萄糖[18F] Fluororo-2-Deoxy-Deoxy-Deoxy-d-d-deprients cance cance cance cance conlistion cance conlistion cance inction cance conlistion cance insive cance insive cance/ct的实用性和成本效益。中性粒细胞减少没有明显的可识别来源，从而改善了靶向治疗。此快速审核赠款应用程序的直接目标是在较小的患者中进行试点项目，以提供重要的信息，以支持较大的多中心临床试验的概念并帮助设计。这项探索性研究的主要目的是对大约130名持续的热中性粒细胞减少症患者进行FDG-PET/CT进行FDG-PET/CT，其中尚未发现明显的感染来源。每个可疑地点将尽可能用病理基础真理确认。将评估数据以解决以下问题，该问题是该提案的子信息：1。FDG-PET/CT在识别具有持续的狂热性中性粒细胞减少症状的癌症患者中有效的有效性？ 2。FDG-PET/CT在多大程度上改善了单独使用CT的感染部位的检测？ 3。哪种FDG-PET/CT成像变量可以最好地预测特定部位的感染（例如，标准化的摄取值[SUV]，CT伴随异常）？ 4。通过SUV在感染部位测量的FDG摄取的大小可以预测感染剂的身份（细菌与真菌与病毒）的身份？ 5。感染部位的摄取幅度是否与绝对中性粒细胞计数相关？ 6。是否可以开发临床评分系统来识别FDG-PET/CT可能在识别感染部位最有效的患者？ FDG-PET/CT可能能够显着改变持续的高热中性粒细胞减少症的癌症患者的治疗，从而改善临床护理；减少因某些有毒抗生素的毒性而引起的发病率；通过改善抗生素疗法的靶向，可能会降低医疗保健成本；并减少这些患者的住院天数。所有这些潜在的收益可能会节省大量成本。 FDG-PET/CT可能能够显着改变持续热中性粒细胞减少症的癌症患者的治疗。 FDG-PET/CT可能是定位神秘源和潜在威胁生命的感染来源的最合适的方法，因此可以直接影响治疗，这可能会通过降低发病率和死亡率来显着影响非常不良癌症患者的生活质量。