CONFORMAL RADIOACTIVE PLAQUES FOR INTRAOCULAR MELANOMA

放射治疗是最常用的眼睛和视力保护替代眼球摘除术与脉络膜黑色素瘤。眼（放射性）斑（OP）形式的近距离放射治疗是治疗脉络膜黑色素瘤的成功方法。在保留视力和最大限度地减少并发症的同时，眼斑放射治疗提供了极好的（>92%）局部控制率。当前一代的眼用板，60 Co、106 Ru板、125 I和103 pd种子对于剂量递送来说不太理想，具有原始的设计，涉及陈旧且低效的制造程序，并且具有一个或多个缺陷。我们建议开发一种基于带电粒子活化过程的新的眼斑，其允许制造直接嵌入薄箔中的广泛均匀的源。该技术允许自动化定制制造OP，使源强度与肿瘤的形貌相匹配。这种适形辐射眼斑（CROP）将使肿瘤剂量最大化，并使对邻近辐射敏感组织的无意剂量最小化。第一阶段的应用证明了该工艺的可行性。与一位领先的眼科医生和OP近距离放射治疗的拥护者之一进行了撕裂安排，以评价适形放射眼科斑块的临床性能，并证明该项目的成功。拟议的商业应用：眼科斑块的市场很小。这种产品的美国市场估计约为1500台/年。在海外也有同样数量的病人。如果我们假设每个斑块使用多达40个种子，每个种子的平均成本为50美元，并且相关的组装成本约为3000美元，则新一代OP在美国的潜在市场为4，500，000美元。对于患有视网膜母细胞瘤的婴儿，存在大致相同大小的市场，其中迫切需要薄的眼斑块。OP用于治疗年龄相关新生血管有相当大的潜在市场。

Radiation is the most frequently used eye and vision-sparing alternative to enucleation of eyes with choroidal melanoma. Brachytherapy, in the form of ophthalmic (radioactive) plaques (OP) is a successful approach for treatment of choroidal melanoma. While preserving vision and minimizing complications, ophthalmic plaque radiotherapy has offered excellent (>92%) local control rates. Current generation ophthalmic plaques, 60Co, 106Ru plates,125I, and 103pd seeds, are less than ideal for dose delivery, have a primitive design, involve antiquated and inefficient manufacturing procedures, and suffer from one or more deficiencies. We propose developing a new ophthalmic plaque based on a charged particle activation process, which allows for manufacturing a broad uniform source, directly embedded in a thin foil. This technology allows for automated custom manufacturing of OPs that match the source intensity to the topography of tumor. Such conformal radiation ophthalmic plaques (CROP) will maximize the tumor dose and minimize the unintentional dose to neighboring radiosensitive tissues. The Phase I application demonstrated feasibility of the process. Tearing arrangements have been made with a leading ophthalmologist and one of the champions of brachytherapy by OP to evaluate the clinical performance of the conformal radiation ophthalmic plaques and demonstrate the success of the project. PROPOSED COMMERCIAL APPLICATION: The market for ophthalmic plaques is small. The U.S. market for such a product is estimated to be around 1500 units/year. There are an equal number of patients overseas. If we assume each plaque uses up to 40 seeds at an average cost of $50 per seed and the associated assembly costs to be approximately $3000, the potential market for new generation OPs is $4,500,000 in the U.S. There is a market of approximately equal size for infants suffering from retinoblastoma where there is a dire need for a thin ophthalmic plaque. There is a sizeable potential market for the OPs for treatment of age related neovascularization.