Robot-Assisted Platform for Intratumoral Delivery

描述（由申请人提供）：前列腺癌的肿瘤内治疗包括通过微创经会阴入路的近距离放疗或消融能量源和腺病毒注射。它们需要定量的、优化的治疗计划，根据治疗计划精确放置针头/探针，以及在发现与治疗计划偏差时在手术室进行实时剂量学评估。最近的研究表明，使用手工技术的标准近距离放射治疗的不精确导致的并发症发生率高于先前所认识的，并且可能是15%的患者局部失败的原因。本研究的主要目标是开发用于前列腺癌综合治疗的肿瘤内递送机器人辅助平台（RAPID），并通过实验室/模拟试验和I期临床研究证明其安全性、有效性和临床效果。生物工程研究合作伙伴之前开发的一些成熟的组件技术将在这次主要合作中结合起来，包括第一个具有实际患者治疗早期经验的泌尿外科应用机器人系统，第一个具有术中剂量优化的治疗计划系统，以及第一个用于实时超声治疗验证的针/探针跟踪系统。允许重新规划和重新优化治疗交付。集成的RAPID系统基于每个研究合作伙伴开发的原型子系统设计，最初将专注于前列腺癌的间质近距离放射治疗。它旨在快速提供精确、非共面3D适形辐射，并确保一致性，并结合放射增敏和混合剂/强度近距离治疗等复杂的并发治疗。主要结果变量包括种植体质量、成本、发病率和学习曲线，将在临床研究中通过与历史对照进行比较。RAPID项目的长期目标是将前列腺癌和其他器官系统的肿瘤内伴随治疗药物的输送纳入其中。RAPID系统的多代理、多模式能力将不断被利用，以全面优化实体器官局部癌症的体内诊断和治疗引擎。

DESCRIPTION (provided by applicant): Intratumoral therapies of prostate cancer include the delivery of brachytherapy or ablation energy sources, and adenoviral injection, through a minimally invasive, transperineal approach. They require quantitative, optimized treatment planning, precise placement of the needles/probes according to the treatment plan, and real time dosimetric evaluation in the operating room as deviations from the treatment plan are detected. Recent studies suggest that imprecisions in standard brachytherapy using the manual technique cause higher than previously appreciated complication rates, and may be the cause of local failure in 15% of the patients. The major goal of the proposed work is to develop the Robot-Assisted Platform for Intratumoral Delivery (RAPID) for integrated treatment of prostate cancer, and to demonstrate the safety, efficacy and clinical effectiveness through bench/phantom tests and a Phase I clinical study. A number of maturing component technologies previously developed by the bioengineering research partners will be combined in this major collaboration, including the first robotic system for urological applications with early experience on actual patient treatment, the first treatment planning system with intraoperative dosimetry optimization, and the first needle/probe tracking system for real time ultrasound-based treatment verification, permitting re-planning and re-optimization of therapy delivery. The integrated RAPID system, designed based on prototype subsystems developed at each of the research partners, will initially focus on interstitial brachytherapy of prostate cancer. It is aimed at delivering precise, non-coplanar 3D conformal radiation rapidly and with assured consistency, and to incorporate such complex concurrent therapies as radiosensitization and mixed agent/strengths brachytherapy. Primary outcome variables including implant quality, cost, morbidity and learning curve will be examined under the clinical study by comparison with historical controls. The long-term objective of the RAPID project is to incorporate the delivery of concomitant therapeutic agents intratumorally for cancer in the prostate as well as in other organ systems. The multi-agent, multi-modality capabilities of the RAPID system will be continually exploited towards total optimization of a turnkey in vivo diagnosis and therapy engine for localized cancers of solid organs.