Multi-Modality MRI/CT Markers for Improved Assessment of Prostate Cancer

 描述（由申请人提供）：近距离放射治疗（放射性粒子植入）是美国每年233，000名前列腺癌患者中多达35，000人选择的治愈性治疗方案。近距离放射治疗可以产生良好的治疗效果，但这些效果取决于所提供的治疗质量，而治疗质量又取决于粒子的定位。C4 Imaging已成功证明并获得FDA 510（k）批准，用于基于MRI标记的放射性粒子定位方法。它解决了通过更好的解剖描绘来改善接受前列腺近距离放射治疗的男性的治疗评估（剂量测定）的需求。增强的MRI/CT标记将允许临床医生将MRI的最佳解剖成像和CT的设备识别结合起来，以进一步改善治疗计划和评估。本提案的总体目标是通过修改之前FDA批准的C4 MRI标记物来开发和实施增强型多模态MRI/CT标记物。如果用含有阳性信号MRI C4溶液的多孔陶瓷插入物替换每个MRI标记物的当前液体填充物，则可以实现器械制造的改进。原型已经确定，高度多孔陶瓷锆芯可以解决这一问题，并将为器械增加CT临床成像能力。MRI/CT标记将接受ISO 10993生物相容性试验，然后在生产意图成品器械的生产后、基于体模的MR和CT功能评估中进行确认。然后，经过充分验证的设备将通过完整的组装周期（包括伽马和环氧乙烷灭菌）准备用于临床使用，并评估犬肿瘤模型中的放射性种子定位。生成的数据将用于支持FDA 510（k）批准。C4 Imaging在这一研究领域取得了成功，并有资格执行本提案中概述的工作。该团队积极开发基于正信号MRI解决方案的MRI技术;拥有医疗器械开发和制造经验;并拥有前列腺癌医疗器械临床使用和营销方面的专业知识。

 DESCRIPTION (provided by applicant): Brachytherapy (radioactive seed implantation) is an option for curative treatment chosen by up to 35,000 of the 233,000 men who develop prostate cancer in the United States each year. Brachytherapy can produce excellent treatment outcomes, but those outcomes vary depending on the quality of the treatment delivered, which in turn depends on the positioning of the seeds. C4 Imaging has successfully demonstrated and received FDA 510(k) clearance for an MRI Marker based approach to radioactive seed localization. It addresses the need to improve treatment assessment (dosimetry) for men who undergo prostate brachytherapy through better anatomical delineation. An enhanced MRI/CT Marker will allow clinicians to incorporate both MRI's optimal anatomical imaging and CT's device identification to further improve treatment planning and assessment. The overall goal of this proposal is to develop and implement an enhanced multi-modality MRI/CT marker by modifying the previous FDA approved C4 MRI Marker. Improvements in device fabrication could be achieved if the current liquid fill of each MRI Marker were replaced by porous ceramic insert containing the positive-signal MRI C4 solution. Prototyping has identified that a highly porous ceramic zirconium core could address this and would add CT clinical imaging capabilities to the device. The MRI/CT Markers will undergo ISO 10993 biocompatibility testing before being validated in post-production, phantom-based MR and CT functional assessment of production intent finished devices. Fully validated devices will then be prepared for clinical use through a full assembly cycle that includes gamma and ethylene oxide sterilization and assessed for radioactive seed localization in a canine tumor model. The data generated will be used to support FDA 510(k) approval. C4 Imaging has demonstrated success in this area of research and is qualified to perform the work outlined in this proposal. The team is active in developing MRI technology based on a positive-signal MRI solution; have experience in medical device development and fabrication; and have expertise in the clinical use and marketing of medical devices used in prostate cancer.