Robot-Assisted Platform for Intratumoral Delivery

描述(申请人提供)：前列腺癌的肿瘤内治疗包括通过会阴微创途径提供近距离放射治疗或消融能源，以及腺病毒注射。它们需要定量、优化的治疗计划，根据治疗计划精确放置针头/探头，并在检测到与治疗计划的偏差时在手术室进行实时剂量学评估。最近的研究表明，在使用手动技术的标准近距离放射治疗中，不精确会导致比先前估计的更高的并发症发生率，并可能是15%的患者局部失败的原因。这项拟议工作的主要目标是开发用于前列腺癌综合治疗的机器人辅助肿瘤内递送平台(RAPID)，并通过工作台/体模试验和I期临床研究证明其安全性、有效性和临床有效性。生物工程研究伙伴以前开发的许多成熟组件技术将结合在这项重大合作中，包括第一个在实际患者治疗方面具有早期经验的用于泌尿外科应用的机器人系统，第一个具有术中剂量学优化的治疗计划系统，以及第一个用于实时基于超声的治疗验证的针/探头跟踪系统，从而允许重新规划和重新优化治疗交付。集成的快速系统是根据每个研究伙伴开发的原型子系统设计的，最初将专注于前列腺癌的间质内放射治疗。它的目标是快速提供精确的、非共面的3D适形放射，并确保一致性，并结合诸如放射增敏和混合剂/强度近距离放射治疗等复杂的同时治疗。包括植入质量、成本、发病率和学习曲线在内的主要结果变量将在临床研究中通过与历史对照进行比较来检验。RAPID项目的长期目标是将治疗前列腺癌和其他器官系统癌症的伴随治疗药物纳入肿瘤内。RAPID系统的多代理、多模式能力将继续被开发，以实现对实体器官局部癌症的整体统包体内诊断和治疗引擎的全面优化。

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.