CONFORMAL RADIOACTIVE PLAQUES FOR INTRAOCULAR MELANOMA

对于脉络膜黑色素瘤患者的眼球摘除手术，放射治疗是最常用的眼部和视力保护方案。以眼部(放射性)斑块(OP)为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。在保护视力和最大限度减少并发症的同时，眼斑放射治疗提供了出色的(92%)局部控制率。当前一代的眼科斑块，60Co、106Ru板、125I和103pd种子，不太适合剂量传递，设计原始，涉及过时和低效的制造工艺，并存在一个或多个缺陷。我们建议开发一种基于带电粒子激活过程的新的眼科斑块，该过程允许制造广泛的均匀源，直接嵌入薄片中。这项技术允许自动定制制造OP，使源强度与肿瘤的地形相匹配。这种适形放射眼斑(CROP)将使肿瘤剂量最大化，并将对邻近放射敏感组织的意外剂量降至最低。第一阶段的应用证明了该工艺的可行性。OP已经与一位领先的眼科医生和近距离放射治疗的领军者之一进行了撕裂安排，以评估适形放射眼斑的临床表现，并展示该项目的成功。拟议的商业应用：眼科斑块的市场很小。据估计，美国市场对这类产品的需求约为1500台/年。在海外也有同样数量的患者。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，相关的组装成本约为3000美元，则新一代OP的潜在市场在美国为450万美元。对于患有视网膜母细胞瘤的婴儿来说，存在着一个大致相同大小的市场，那里迫切需要一个薄的眼部斑块。OPS在治疗年龄相关性新生血管方面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.