Novel Conformal Iodine-125 Ophthalmic Plaques

新型适形碘 125 眼科斑块

• 批准号: 6689781
• 负责人: John J Munro
• 金额: $ 35.56万
• 依托单位: IMPLANT SCIENCES CORPORATION
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6689781
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; eye neoplasms; iodine; melanoma; neoplasm /cancer radionuclide therapy; optic nerve; radionuclide implant; xenon

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.

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，在美国每年报告约1500例新发病例。这些肿瘤都是视力和生命的威胁。中等脉络膜黑色素瘤的COMS试验表明，单独使用125碘放射性斑块治疗，不进行摘除术，不会增加死亡率。中等大小的脉络膜黑色素瘤可以通过应用125碘近距离放射治疗来治疗，并保留眼睛和一些视力。然而，由当前使用的“接种”斑块产生的剂量分布是不均匀的并且高度复杂。如果不是不可能的话，在眼睛内甚至肿瘤内的不同点处精确地实现期望的辐射剂量分布是极其困难的。治疗后，超过40%的眼睛经历了严重的放射相关眼部并发症。 该II期计划旨在开发一种用于治疗脉络膜黑色素瘤的改进的近距离放射治疗斑块。该放射源将通过一种工艺制造，通过该工艺，可以设计斑块表面上的125碘分布，以提供规定的剂量分布。 这样的发展将提供比当前的种子斑更好的剂量均匀性，并且将允许剂量分布被轮廓化以符合特定的肿瘤。这样的发展也将提供定制斑块设计的措施，提供诸如视神经的干扰周围的调节和间隙。此外，这种斑块将实现剂量率的高度定制，允许在非常窄的限制内指定治疗时间。 该斑块将比当前接种的斑块更薄，这将为患者提供更小程度的不适。这种斑块将被设计为可重复使用，大大降低了这部分治疗的成本。使用125碘的适形近距离放射治疗斑块可以是这种癌症的有效治疗装置。