Absorbable and Low-Cost Radioseeds for Malignant Tumors

用于恶性肿瘤的可吸收且低成本的放射种子

基本信息

批准号：
7486650
负责人：
YONGREN Benjamin PENG
金额：
$ 36.12万
依托单位：
XL SCI-TECH, INC.
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-05-11 至 2009-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7486650
关键词：
90Y Brachytherapy Calcium Caliber Chemicals Chemistry Chromosome abnormality Clinical Combined Modality Therapy Compatible Condition Dependence Depth Dimensions Dimethyl Sulfoxide Dose Dose-Rate Encapsulated Engineering Ensure Evaluation External Beam Radiation Therapy Extravasation Glass Half-Life Hour Image Imaging technology Implant In Vitro Individual Institutes Iron Knowledge Lead Length Linear Regressions Logistics Malignant Neoplasms Malignant neoplasm of liver Malignant neoplasm of prostate Mammalian Cell Measurable Measures Methods Microspheres Modeling Monitor Mutation Operative Surgical Procedures Palladium 103 Partner in relationship Personal Satisfaction Phase Principal Investigator Production Prostate Prostatic Neoplasms Purpose Radiation, Other Radio Radioactivity Radioseeds Range Rate Research Research Personnel Seeds Surface Technology Temperature Testing Therapeutic Time Tissues Titanium Toxic effect Toxicology Treatment Cost Ultrasonography Week X-Ray Computed Tomography base biomaterial compatibility calcium phosphate cost cytotoxicity day density design dosimetry genotoxicity implantation in vivo innovation inorganic phosphate predictive modeling radiologist time use tissue phantom tumor zinc phosphate

项目摘要

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.

描述（由申请人提供）：该 I 期研究的目的是证明制造定时生物可吸收 Pd-103 种子用于治疗前列腺肿瘤的可行性。定时生物可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方案的综合优点。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体治疗成本。这项拟议的快速通道第一阶段研究的具体目标是（1）确定具有适当的内在生物吸收率并且适合生物吸收曲线的工程控制的可吸收基质； (2) 确定种子尺寸以实现最佳成像； (3) 控制生物吸收，使种子中 Pd-103 放射性累积泄漏量小于或等于 1%，并预计在 2 年内种子基质完全生物吸收； (4) 确定并推荐最佳基质化学和生物吸收工程条件，以深入研究快速通道二期中的 Pd-103 泄漏和生物吸收曲线； (5) 使用 ISO 方法在体外证明选定的定时生物可吸收种子的生物相容性。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生物可吸收种子。