Novel Conformal Iodine-125 Ophthalmic Plaques

描述（由申请人提供）：脉络膜黑色素瘤是最常见的原发性眼部恶性肿瘤，在美国每年约有1500例新病例报告。这些肿瘤不仅危及视力，而且危及生命。COMS对中度脉络膜黑色素瘤的试验表明，125碘放射性斑块单独治疗，不去核，不会增加死亡率。应用125碘近距离放射治疗可以治疗中等大小的脉络膜黑色素瘤，并能保护眼睛和部分视力。然而，目前使用的“种子”斑块产生的剂量分布不均匀且高度复杂。要在眼内甚至肿瘤内的不同位置准确地达到所需的辐射剂量分布，即使不是不可能，也是极其困难的。治疗后，超过40%的眼睛经历了明显的放射相关眼部并发症。该II期项目旨在开发一种用于脉络膜黑色素瘤治疗的改进近距离治疗斑块。该源将通过一种工艺来制造，通过该工艺，可以设计斑块表面的125碘分布以提供规定的剂量分布。这种发展将比目前的种子斑块提供更好的剂量均匀性，并允许剂量分布符合特定肿瘤的轮廓。这样的发展也将为斑块的设计提供一种定制化的措施，在视神经等干扰周围提供调节和清除。此外，这种斑块将实现剂量率的高度定制，允许在非常窄的范围内指定治疗时间。这种斑块将比目前的种子斑块更薄，这将给患者带来更小程度的不适。这种菌斑将被设计成可重复使用，大大降低了这部分治疗的成本。使用125碘的适形近距离治疗斑块是治疗这种癌症的有效方法。

DESCRIPTION (provided by applicant): Choroidal melanoma is the most common primary ocular malignancy, with some 1500 new cases reported yearly in the United States. These tumors are both sight- and life-threatening. The COMS trial for medium choroidal melanomas, demonstrated that 125Iodine radioactive plaque treatment alone, without enucleation, does not increase mortality. Medium-sized choroidal melanomas can be treated and the eye and some vision preserved by application of 125Iodine brachytherapy. However, the dose distribution generated by the currently used "seeded" plaques is non-uniform and highly complex. It is extremely difficult if not impossible to accurately achieve the desired radiation dose distribution at varying points within the eye and even within the tumor. After treatment, greater than 40% of eyes have experienced significant radiation associated ocular complications. This Phase II program intends to develop an improved brachytherapy plaque for the treatment of choroidal melanoma. The source would be manufactured through a process by which the 125Iodine distribution on the surface of the plaque could be designed to provide a prescribed dose distribution. Such development would provide better dose uniformity than the current seed plaque and would permit the dose distribution to be contoured to conform to the specific tumor. Such development would also provide a measure of customization to the plaque design, providing accommodations and clearances around interferences such as the optic nerve. Additionally, such plaques would achieve a high degree of customization of the dose rate, allowing the treatment time to be specified within very narrow limits. This plaque would be thinner than the current seeded plaques, which would provide a lesser degree of discomfort to the patient. This plaque would be designed to be reusable, greatly reducing the cost for this portion of the treatment. A conformal brachytherapy plaque using 125Iodine can be an effective treatment device for this cancer.