Analytical Methods for Automated Quality Control of Cancer PET Imaging Tracer - [F-18]FDG

癌症 PET 成像示踪剂 - [F-18]FDG 自动化质量控制的分析方法

• 批准号: 9255787
• 负责人: Arkadij Elizarov
• 金额: $ 85.98万
• 依托单位: TRACE-ABILITY, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-06 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9255787
• 关键词: Achievement; Aliquot; Automation; Brain Neoplasms; Businesses; Cancer Control; Cancer Patient; Chemicals; Choline; Chromatography; Clinical; Computer software; Contrast Media; Data; Deoxyglucose; Development; Devices; Endocrine Gland Neoplasms; Evaluation; Failure; Freezing; Funding; Goals; Half-Life; High Pressure Liquid Chromatography; Image; Manuals; Manufacturer Name; Measurement; Methods; Molecular; Optics; Patients; Phase; Positioning Attribute; Positron-Emission Tomography; Procedures; Process; Production; Prostatic Neoplasms; Quality Control; Radioactive; Radiopharmaceuticals; Reader; Records; Reporting; Risk; Sampling; Scanning; Site; Small Business Innovation Research Grant; System; Technology; Testing; Time; Tracer; United States National Institutes of Health; Validation; Visual; analytical method; base; cancer type; clinical imaging; cost; cost efficient; design; glucose production; imaging modality; innovation; oncology; operation; prototype; radiochemical; skills; standard of care; tumor

Project Summary Positron Emission Tomography (PET) is regarded as a standard of care in the management of multiple types of cancer. Availability of this procedure relies on a steady supply of a radioactive contrast agent [F- 18]Fluoro-2-deoxy-d-glucose (FDG). Due to the inherent short half-life (110 min), multiple batches of FDG are typically produced at multiple sites on daily basis. Quality Control (QC) of FDG remains the most labor-, skill- and risk-intensive part of the production process. Reliance of QC on manual operation, subjectivity and untraceable records, limits the number of FDG batches that may be produced per day per facility, which in turn limits availability of PET imaging to cancer patients. Trace-Ability has taken an unconventional approach to QC automation (called Tracer-QC) which relies on optical measurements by a microplate reader for most of the QC tests. The innovation is in the disposable kit that enables multiple tests from a single sample on a single platform composed of a microplate reader and automated pipettor. Most of the QC tests have been already enabled by Trace-Ability relying on NCI Phase I SBIR and other funding. Radiochemical purity and chemical identity QC tests will be enabled during Phase II by integration of an HPLC component into the plate reader/pipettor system in a seamless way which allows the user to use a single sample to obtain a single report on 10 QC parameters. The integrated solution will then be validated for use in clinical FDG production. The second component of the Phase II project will focus on setting up reliable production of disposable Tracer-QC kits at commercial scale. Upon achievement of the above aims, Trace-Ability will be in position to offer FDG manufacturers a fully-automated QC solution that has been completely validated. This is critical since production of short- lived PET tracers has extremely low tolerance for failure. Optimized production processes will yield Tracer-QC kits that are not only optimized for reliability, but also for cost, maximizing the commercial potential of the Tracer-QC business that relies on recurring kit revenues from the growing install base. Finally, having an FDG QC solution with on-board HPLC enables expansion of Tracer-QC to any other PET tracers without further revisions of the stationary hardware, making it a true scalable platform. The impact in the field of Oncology will be manifested in increased availability of FDG scans and facilitation of new tracer development. Upon completion of the project Trace-Ability plans to use the new platform to develop QC methods for more PET tracers such as [F-18]FDOPA (brain tumors), [F-18]FLT (general oncological tracer), [C-11]Choline (prostate tumors), [Ga-68]DOTATOC (endocrine tumors).

项目摘要 正电子发射断层扫描（PET）被认为是治疗多发性骨髓瘤的标准方法。 癌症的类型。该程序的可用性依赖于放射性造影剂的稳定供应[F-10]。 18]氟-2-脱氧-d-葡萄糖（FDG）。由于固有的短半衰期（110分钟），多批次的 FDG通常每天在多个地点生产。FDG的质量控制（QC）仍然是最重要的 生产过程中的劳动、技能和风险密集型部分。QC对手动操作的依赖， 主观性和不可追溯的记录，限制了每天生产的FDG批次数量， 这反过来又限制了PET成像对癌症患者的可用性。 Trace-Ability采用了一种非传统的QC自动化方法（称为Tracer-QC）， 大多数QC测试依赖于酶标仪的光学测量。创新在于 一次性试剂盒，能够在单个平台上对单个样品进行多次测试， 酶标仪和自动移液器。Trace-Ability已启用大多数QC测试 依靠NCI第一阶段SBIR和其他资金。放射化学纯度和化学鉴别QC检测将 通过将HPLC组件集成到酶标仪/移液器系统中， 无缝方式，允许用户使用单个样品获得关于10个QC参数的单个报告。 然后将验证集成解决方案是否可用于临床FDG生产。第二部件 第二阶段项目的重点是建立一次性Tracer-QC套件的可靠生产， 商业规模。 在实现上述目标后，Trace-Ability将能够为FDG制造商提供 经过全面验证的全自动QC解决方案。这一点至关重要，因为生产短- 活性PET示踪剂具有极低的故障容忍度。优化的生产工艺将产生 Tracer-QC套件不仅针对可靠性进行了优化，而且还针对成本进行了优化，最大限度地提高了商业价值。 Tracer-QC业务的潜力依赖于不断增长的安装基础带来的经常性套件收入。 最后，配备机载HPLC的FDG QC解决方案可将Tracer-QC扩展到任何其他 PET示踪剂无需进一步修改固定硬件，使其成为真正的可扩展平台。 在肿瘤学领域的影响将表现在FDG扫描的可用性增加， 促进新示踪剂的开发。项目完成后，可追溯性计划使用新的 为更多PET示踪剂（如[F-18]FDOPA（脑肿瘤）、[F-18]FLT）开发QC方法的平台 （一般肿瘤示踪剂），[C-11]胆碱（前列腺肿瘤），[Ga-68]DOTATOC（内分泌肿瘤）。