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

 描述(申请人提供)：近距离放射治疗(放射性粒子植入)是一种治疗方法，美国每年有23.3万名前列腺癌患者选择近距离放射治疗，其中多达3.5万人选择了这种治疗方法。近距离放射治疗可以产生极好的治疗结果，但这些结果取决于提供的治疗质量，而治疗质量又取决于种子的位置。C4成像已经成功地证明并获得了FDA 510(K)对基于MRI Marker的放射性种子定位方法的批准。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(剂量学)的需要。增强的MRI/CT Marker将允许临床医生将MRI的最佳解剖成像和CT的设备识别结合在一起，以进一步改进治疗计划和评估。这项提案的总体目标是通过修改FDA批准的C4 MRI标记物来开发和实施增强型多模式MRI/CT标记物。如果每个MRI Marker的当前液体填充被包含正信号MRI C4溶液的多孔陶瓷插件取代，则可以实现设备制造的改进。原型设计已经确定，一个高度多孔的陶瓷锆芯可以解决这个问题，并将为该设备增加CT临床成像能力。核磁共振/CT标记将经过国际标准化组织10993生物兼容性测试，然后在后期生产、基于幻影的MR和CT功能评估中得到验证。然后，经过充分验证的设备将通过包括伽马和环氧乙烷灭菌在内的整个组装周期准备用于临床，并在犬肿瘤模型中评估放射性种子定位。生成的数据将用于支持FDA 510(K)的批准。C4成像公司已证明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；在医疗设备开发和制造方面拥有经验；在前列腺癌医疗设备的临床使用和营销方面拥有专业知识。

 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.