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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：
10453651
负责人：
YONGREN Benjamin PENG
金额：
$ 116.57万
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 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10453651
关键词：
90Y Advanced Development Arteries Biological Calibration 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 liver cancer patient 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.

项目总结/文摘