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）被视为多重管理的护理标准 癌症类型。此程序的可用性取决于放射性对比剂的稳定供应[F- 18]氟-2-脱氧-D-葡萄糖（FDG）。由于固有的短半衰期（110分钟），多批 FDG通常每天在多个地点生产。 FDG的质量控制（QC）仍然是最大的 生产过程的劳动力，技能和风险密集型部分。依靠质量控制对手动操作的依赖， 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 该设施又将PET成像的可用性限制在癌症患者中。 痕量能力采用了QC自动化的非常规的方法（称为Tracer-QC），该方法 在大多数QC测试中，微孔板读取器依靠光学测量。创新在 一次性套件，可以从单个平台上的单个样本进行多个测试，由单个平台组成 微板读取器和自动化移液器。大多数QC测试已经通过跟踪性启用 依靠NCI I期SBIR和其他资金。放射化学纯度和化学身份QC测试将 通过将HPLC组件集成到板读取器/移液器系统中，可以在II阶段启用 无缝的方式，允许用户使用单个样本在10个QC参数上获得单个报告。 然后，将综合解决方案验证用于临床FDG生产。第二个组件 第二阶段项目的重点是设置可靠的一次性示踪QC套件的生产 商业规模。 一旦实现了上述目标，痕量性将有能力为FDG制造商提供 已完全验证的完全自动化的QC解决方案。这是至关重要的，因为短期生产 生活的宠物示踪剂对失败的容忍度极低。优化的生产过程将产生 Tracer-QC套件不仅针对可靠性进行了优化，而且还针对成本，最大化广告 Tracer-QC业务的潜力依赖于不断增长的安装基础的重复套件收入。 最后，在板载HPLC的FDG QC解决方案中，可以将Tracer-QC扩展到任何其他 宠物示踪剂没有固定硬件的进一步修订，使其成为真正可扩展的平台。 肿瘤学领域的影响将在FDG扫描的可用性增加和 新示踪剂开发的促进。项目完成后，痕量能力计划使用新的 开发QC方法的平台，用于更多宠物示踪剂，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）。