Absorbable and Low-Cost Radioseeds for Malignant Tumors

描述（由申请人提供）：本I期研究的目的是证明创造用于治疗前列腺肿瘤的定时生物吸收Pd-103种子的可行性。定时生物吸收种子具有钛种子、高剂量率临时种子、外束辐射和其他治疗选择的综合好处。此外，定时生物吸收种子可能提供理想的治疗后选择，植入物的总生物吸收和最低的总体治疗成本。这项拟议的快速通道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合生物吸收谱工程控制的可吸收基质；(2)确定最佳成像种子尺寸；(3)控制生物吸收，使种子累积泄漏的Pd-103放射性物质不超过1%，并在2年内估计种子基质的完全生物吸收；(4)确定并推荐最佳的基质化学和生物吸收工程条件，以深入研究快速通道II期的Pd-103泄漏和生物吸收剖面；(5)利用ISO方法证明了所选定时生物吸收种子的体外生物相容性。实现I期设定的关键和可衡量的里程碑将确保拟议的快速通道II期的成功完成，从而为前列腺肿瘤和其他恶性肿瘤的治疗提供高影响生物吸收种子。

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.