PET Enabled Microspheres for Radioembolization of Liver Tumors

用于肝脏肿瘤放射栓塞的 PET 微球

基本信息

批准号：
8782336
负责人：
YONGREN Benjamin PENG
金额：
$ 75.55万
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 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8782336
关键词：
90Y Advanced Development Animal Model Arteries Blood Caliber Calibration Cancer Patient Chronic Clinical Clinical Trials Control Groups Data Development Devices Diagnostic Imaging Dose Encapsulated Ensure Evaluation Exposure to Extravasation Glass Hemolysis Hour Human Human Resources Image In Vitro Investigation Lasers Lead Liver neoplasms Malignant neoplasm of liver Measures Methods Microfabrication Microspheres Modeling Molecular Conformation Mus Muscle Neoplasm Metastasis Ohio Optics Organ Outcome Palliative Care Patient Agents Patients Phase Polymers Positron Positron-Emission Tomography Preparation Primary Neoplasm Process Production Property Radial Radiation Radio Radioembolization Radioisotopes Reflux Research Resolution Risk Roswell Park Cancer Institute Safety Scanning Simulate Technology Therapeutic Therapeutic Embolization Time Tissues Toxic effect Treatment Efficacy Unresectable biomaterial compatibility cost density design dosimetry gastrointestinal implantation improved in vivo innovation micronucleus patient safety peripheral blood pre-clinical preclinical efficacy predictive modeling public health relevance response simulation standard measure treatment planning tumor

项目摘要

DESCRIPTION (provided by applicant): 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 along with Y-90. All key feasibilities have been demonstrated as proposed. This proposed Phase II research focuses on the preparation of radioembolic Y-90 microspheres at therapeutic levels of Y-90 with enhanced personnel safety and focuses on the calibration of Y-90 dose distribution that are critical and practical for real-time Y-90 dosimetry o improve much desired efficacy. The objectives of this proposed Phase II research is (1) to establish micro-fabrication process for on-demand production of Y-90 microspheres that are patient specific for dose planning and Y-90 radioembolization; (2) to reliably assess Y-90 distribution in real-time and to calibrate Y-90 dosimetry also in real-time to minimize patient safety risk and to maximize treatment efficacy; (3) to establish acceptable preclinical biocompatibility and radio-toxicity in order to gain FDA acceptance for human clinical investigation; and (4) to demonstrate preclinical efficacy in an appropriate animal model through correlating Y-90 dose distributions and tumor responses. Successful completion of the proposed Phase II research will likely improve patient safety, will likely advance Y- 90 radioembolization from palliative treatment to curative treatment for liver cancer. In addition, this advanced development has the potential to drastically reduce the cost of Y-90 radioembolization agents such that this treatment option is more affordable.

描述（由申请人提供）：目前的放射性栓塞Y-90微球已被普遍认为是治疗原发性和转移性肝脏肿瘤的最先进技术。然而，由于缺乏准确的剂量和治疗计划诊断成像，以及Y-90微球给药过程中缺乏图像引导和剂量构象，临床结果差异很大。研究小组已经确定了将 PET 显像剂与 Y-90 一起使用的可行性。所有关键的可行性均已按建议进行论证。这项拟议的 II 期研究重点是制备 Y-90 治疗水平的放射性栓塞 Y-90 微球，以提高人员安全性，并重点关注对实时 Y-90 剂量测定至关重要且实用的 Y-90 剂量分布校准o 提高许多期望的功效。这项拟议的第二阶段研究的目标是（1）建立按需生产 Y-90 微球的微制造工艺，该微球是针对患者特定的剂量计划和 Y-90 放射栓塞； (2) 实时可靠地评估 Y-90 分布并实时校准 Y-90 剂量测定，以最大限度地降低患者安全风险并最大限度地提高治疗效果； (3) 建立可接受的临床前生物相容性和放射毒性，以获得 FDA 接受人体临床研究； (4) 通过关联 Y-90 剂量分布和肿瘤反应，在适当的动物模型中证明临床前疗效。成功完成拟议的 II 期研究将可能提高患者的安全性，并可能将 Y-90 放射栓塞从肝癌的姑息治疗推进到根治性治疗。此外，这一先进的开发有可能大幅降低 Y-90 放射栓塞剂的成本，从而使这种治疗选择更加实惠。