PET Enabled Y-90 Microspheres for Radioembolization of Liver Tumors

用于肝脏肿瘤放射栓塞的 PET 启用 Y-90 微球

基本信息

批准号：
10250747
负责人：
YONGREN Benjamin PENG
金额：
$ 112.05万
依托单位：
XL SCI-TECH, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10250747
关键词：
90Y Advanced Development Arteries Biological Calibration Cancer Patient China Clinical Companions Development Devices Diagnostic Imaging Discipline of Nuclear Medicine Documentation Dose Encapsulated Extravasation Glass Hemolysis Heterogeneity Human Human Resources Image International Investigation Isotopes Label Lead Liver neoplasms Lung Malignant neoplasm of liver Measures Metastatic Neoplasm to the Liver Microfabrication Microspheres Molecular Conformation Mus Neoplasm Metastasis Neutrons Nuclear Reactors Organ PET/CT scan Palliative Care Patients Phase Positron-Emission Tomography Preparation Primary Malignant Neoplasm of Liver Primary Neoplasm Process Production Property Radioactive Radioembolization Radioisotopes Reflux Research Risk Risk Assessment Safety Shunt Device Technetium 99m Technetium Tc 99m Aggregated Albumin Therapeutic Therapeutic Embolization Time Tissues X-Ray Computed Tomography Y base accurate diagnostics biomaterial compatibility chemical property clinical investigation commercialization cost curative treatments dosimetry experience gastrointestinal image guided imaging agent improved in vivo micronucleus next generation overdose risk patient safety peripheral blood physical property research clinical testing single photon emission computed tomography systemic toxicity treatment planning tumor

项目摘要

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.

项目概要/摘要目前的放射性栓塞 Y-90 微球已被普遍认为是治疗癌症的最先进技术原发性和转移性肝脏肿瘤。然而，由于缺乏准确的数据，临床结果差异很大。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构象 Y-90微球给药期间。调查组已确定可行性单独使用 PET 显像剂或与 Y-90 一起使用。所有关键的可行性均已被证明为在第一阶段和第二阶段提出。这项拟议的 IIB 期研究重点是放射性栓塞 Y-的制备 90 微球处于 Y-90 的治疗水平，增强了人员安全性，该研究还重点关注关于 Y-90 剂量分布的校准，这对于实时 Y-90 剂量测定至关重要且实用提高许多期望的功效。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方法按需生产 PET 发射微球的微加工工艺玻璃成分，(2) 可靠地生产低成本 Y-90 放射性同位素，(3) 评估生物相容性和获得 FDA 接受人体临床研究的生物风险，以及 (4) 证明临床 PET发射玻璃微球的用途。成功完成拟议的 IIB 期研究将开发出支持 PET 的 Y-90 玻璃微球，以提高患者安全并推进 Y-90 肝癌特别是原发性肝癌的放射栓塞从姑息治疗到根治性治疗癌症。此外，这一IIB期先进开发有可能大幅降低成本 Y-90 放射栓塞剂使这种治疗选择除了更实惠之外还更实惠有效的。