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).

项目概要 正电子发射断层扫描 (PET) 被视为多发性硬化症管理的护理标准 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- 18]氟-2-脱氧-d-葡萄糖（FDG）。由于固有的半衰期短（110分钟），多批次 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 生产过程中劳动力、技能和风险密集的部分。 QC 依赖手动操作， 主观性和无法追踪的记录限制了每天可能生产的 FDG 批次数量 设施，这反过来又限制了 PET 成像对癌症患者的可用性。 Trace-Ability 采用了一种非常规的 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。创新之处在于 一次性套件，可在单个平台上对单个样品进行多次测试，该平台由 酶标仪和自动移液器。大多数 QC 测试已由 Trace-Ability 启用 依靠 NCI 一期 SBIR 和其他资金。放射化学纯度和化学特性 QC 测试将 通过将 HPLC 组件集成到读板器/移液器系统中，可在第二阶段启用 无缝方式允许用户使用单个样品获得 10 个 QC 参数的单个报告。 随后将验证集成解决方案是否可用于临床 FDG 生产。第二个组成部分 第二阶段项目的重点是在以下地点建立一次性示踪剂-QC 套件的可靠生产 商业规模。 实现上述目标后，Trace-Ability 将能够为 FDG 制造商提供 经过完全验证的全自动 QC 解决方案。这是至关重要的，因为生产短 活体 PET 示踪剂对失败的容忍度极低。优化的生产流程将产生 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，从而最大限度地提高了商业成本 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，拥有带有机载 HPLC 的 FDG QC 解决方案可以将 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。 对肿瘤学领域的影响将体现在 FDG 扫描的可用性增加和 促进新示踪剂的开发。项目完成后，Trace-Ability 计划使用新的 开发更多 PET 示踪剂的 QC 方法的平台，例如 [F-18]FDOPA（脑肿瘤）、[F-18]FLT （一般肿瘤示踪剂）、[C-11]胆碱（前列腺肿瘤）、[Ga-68]DOTATOC（内分泌肿瘤）。