Absorbable and Low-Cost Radioseeds for Malignant Tumors

描述（由申请方提供）：本I期研究的目的是证明创建定时生物可吸收Pd-103粒子用于治疗前列腺肿瘤的可行性。定时生物可吸收粒子具有钛粒子、高剂量率临时粒子、外部射束辐射和其他治疗选择的综合益处。此外，定时生物可吸收种子可能提供理想的后处理选择，植入物的总生物吸收和最低的总治疗成本。该拟议的快速通道I期研究的具体目标是（1）确定具有适当内在生物吸收率并适用于生物吸收曲线工程控制的可吸收基质;（2）确定最佳成像的种子尺寸;（3）控制生物吸收，使种子中累积Pd-103放射性泄漏为1%（4）确定并推荐最佳基质化学和生物吸收工程条件，用于快速通道II期中Pd-103泄漏和生物吸收特征的深入研究;（5）采用ISO方法对选定的定时生物可吸收种子进行体外生物相容性验证。实现第一阶段设定的关键和可衡量的里程碑将确保成功完成拟议的快速通道第二阶段，从而产生用于治疗前列腺肿瘤和其他恶性肿瘤的高影响力生物可吸收种子。

DESCRIPTION (provided by applicant): The objective of this Phase I research is to demonstrate the feasibility of creating timed-bioabsorbable Pd-103 seeds for the treatment of prostate tumors. Timed- bioabsorbable seeds have the combined benefits of titanium seeds, high dose rate temporary seeds, external beam radiation and other treatment options. In addition, timed-bioabsorbable seeds potentially offer desirable post-treatment options, total bioabsorption of the implants and the lowest overall treatment cost. The specific aims of this proposed Fast Track Phase I research are to (1) identify absorbable matrices that have appropriate intrinsic bioabsorption rates and are suitable for engineered control of bioabsorption profiles; (2) determine seed dimension for optimal imaging; (3) control the bioabsorption such that the cumulative Pd-103 radioactivity leakage from seeds is 1% or less and the complete bioabsorption of seed matrices is estimated within 2 years; (4) determine and recommend optimal matrix chemistry and bioabsorption engineering conditions for in-depth studies of Pd-103 leakages and bioabsorption profiles in the Fast-Track Phase II; and (5) demonstrate the biocompatibility for selected timed-bioabsorbable seeds in vitro using ISO methods. Achieving key and measurable milestones set in Phase I will ensure successful completion of the proposed Fast Track Phase II, leading to high impact bioabsorbable seeds for the treatment of prostate tumors and other malignant tumors.