Targeted Radioactive Particles for Liver Tumors Therapy

用于肝脏肿瘤治疗的靶向放射性粒子

• 批准号: 6663683
• 负责人: Gilles H TAPOLSKY
• 金额: $ 23.34万
• 依托单位: FERX, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-25 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6663683
• 关键词: biomedical equipment development; carbon; drug delivery systems; iron; laboratory rabbit; liver neoplasms; magnetism; microcapsule; neoplasm /cancer radionuclide therapy; nonhuman therapy evaluation; pharmacokinetics; radiopharmacology; radiotracer; swine

DESCRIPTION (provided by applicant): The ability to deliver high doses of radiation (up to 200 Gy and higher) to a tumor without significant damage to surrounding tissue would be a significant advancement in the radiation therapy of solid tumors. FeRx proposes to complete the preclinical and clinical development of targeted radioactive microparticles for the site-specific delivery of radionuclides to liver tumors. Magnetic Targeted Carriers (MTCs) are 0.5 to 5 micron particles composed of metallic iron and activated carbon. Results of SBIR phase I studies indicated that In111, Re188, and Y90 were efficiently and strongly bound to MTCs. Using a small externally positioned magnet, MTCs were effectively targeted to a swine liver where they were trapped. FeRx?s objectives are 1) to perform preclinical studies to support an Investigational Device Exemption submission and 2) to conduct a Phase I/Il safety and tolerability study in patients with liver cancer. In the first year, FeRx will complete the development of (90Y-DOTA)-MTCs, perform biodistribution studies in rabbits and swine, investigate the intra-tumoral biodistribution, and assess the radiotoxicity of high doses of localized radiation. In the second year, FeRx will submit an IDE and commence a phase I/II trial in patients with liver cancer to evaluate safety, tolerability, and preliminary efficacy.

描述（由申请人提供）：递送高剂量的 放射（高达200戈伊和更高）对肿瘤无显著损伤， 将是放射治疗的一个重大进步 实体肿瘤的FeRx建议完成临床前和临床 开发针对特定位点的放射性微粒 将放射性核素递送至肝肿瘤。 磁性靶向载体（MTC）是由以下组成的0.5至5微米颗粒： 金属铁和活性炭。SBIR I期研究结果表明， In 111、Re 188和Y 90与MTCs的结合强度较高。使用 小的外部定位磁体，MTC有效地靶向猪 他们被困的地方。 FeRx？的目标是1）进行临床前研究，以支持 试验用器械豁免提交和2）进行I/II期 肝癌患者的安全性和耐受性研究。第一年， FeRx将完成（90 Y-DOTA）-MTC的开发，进行生物分布 在兔和猪中的研究，研究肿瘤内的生物分布， 并评估高剂量局部辐射的放射毒性。在 第二年，FeRx将提交IDE并开始I/II期试验， 评估肝癌患者的安全性、耐受性和初步 功效