PET Enabled Y-90 Microspheres for Radioembolization of Liver Tumors

项目总结/摘要 目前的放射性栓塞Y-90微球已被普遍认为是最先进的治疗 原发性和转移性肝肿瘤。然而，由于缺乏准确的临床结果， 用于剂量和治疗计划的诊断成像以及缺乏图像引导和剂量确认 在Y-90微球的施用期间。调查小组已经确定了 单独使用PET显像剂或沿着使用Y-90。所有关键特性均已证明为 在第一和第二阶段提出。这项拟议的IIB期研究的重点是制备放射性栓塞Y- 90微球在Y-90的治疗水平，提高了人员的安全性，研究还侧重于 Y-90剂量分布的校准对于实时Y-90剂量测定是关键和实用的， 提高了非常期望功效。这项拟议的IIB期研究的目标是：（1）建立一个 使用商业上可行的微制造方法按需生产PET发射微球 玻璃组合物，（2）可靠地生产低成本Y-90放射性同位素，（3）评估生物相容性， 生物学风险，以获得FDA对人体临床研究的认可，以及（4）证明临床 PET发光玻璃微球的实用性。成功完成拟议的IIB期研究将 导致PET使能Y-90玻璃微球，以提高患者安全性并推进Y-90 肝癌，尤其是原发性肝癌的放射性栓塞从姑息治疗到根治性治疗 癌此外，这一IIB阶段的先进发展有可能大大降低成本， Y-90放射性栓塞剂，使这种治疗选择更实惠，除了更多 有效

Project Summary/Abstract Current radioembolic Y-90 microspheres have been generally recognized as the state-of-the-art for treating primary and metastatic liver tumors. However, the clinical results vary vastly due to the lack of accurate diagnostic imaging for dose and treatment planning and the lack of image guidance and dose conformation during the administration of Y-90 microspheres. The investigation team has established the feasibility of using PET imaging agent alone or along with Y-90. All key feasibilities have been demonstrated as proposed in Phases I & II. This proposed Phase IIB research focuses on the preparation of radioembolic Y- 90 microspheres at therapeutic levels of Y-90 with enhanced personnel safety, and the research also focuses on the calibration of Y-90 dose distribution that is critical and practical for real-time Y-90 dosimetry to improve much desired efficacy. The objectives of this proposed Phase IIB research are (1) to establish a microfabrication process for on-demand production of PET emitting microspheres using commercially viable glass compositions, (2) to reliably produce low-cost Y-90 radioisotope, (3) to assess biocompatibility and biological risks to gain FDA acceptance for a human clinical investigation, and (4) to demonstrate clinical utility of PET emitting glass microspheres. Successful completion of the proposed Phase IIB research will lead to PET-enabled Y-90 glass microspheres to improve patient safety and to advance Y-90 radioembolization from palliative treatment to curative treatment for liver cancer, especially primary liver cancer. In addition, this Phase IIB advanced development has the potential to drastically reduce the cost of Y-90 radioembolization agents so that this treatment option is more affordable in addition to being more effective.