Transrectal Ultrasound Ablation Of The Prostate

描述(由申请人提供)： 前列腺癌仍然是一个重要的健康问题，是美国男性癌症相关死亡的第二大常见原因。前列腺癌的局部复发是最常被发现的初次治疗失败，这将推动后续治疗方案进入攻击性轨道，主要目标是阻止肿瘤扩散，否则患者将迅速发展为危及生命的情况。研究表明，热消融在局部复发前列腺癌的治疗中是有帮助的，无论是作为一种唯一的方式，还是作为外照射放射治疗的辅助前增敏剂。申请者已经在犬的活体实验中证明了高强度间质超声(HIIU)适合于将致癌热剂量高度适形地输送到前列腺。作为自然延续，提出了一种计算机控制的超声图像引导系统，用于使用高强度间质超声经直肠超声图像引导治疗。 第一阶段的目标是(1)开发一种经直肠置针机构，(2)将现有的HIIU装置包装在柔性针中，(3)在图像引导下在体外动物模型上证明该装置的可行性。 第二阶段的目标是设计和实施一个计算机集成系统，具有先进的图像制导、可视化、规划和实时质量控制功能。该系统的独特之处在于，医生可以实时“看到”消融针与理想的热剂量计划的关系，并迅速调整能量的空间分布，以补偿任何差异。该系统最吸引人的因素是，组织消融治疗的结果将不再决定性地取决于设备放置的几何精度，因为合理的空间不准确性可以通过内置的声能传递机制中的电子空间功率分配控制得到安全补偿。 最终的系统将在犬类受试者身上进行测试，并以有限的方式在人类患者身上进行测试。拟议研究的终点是一个可以寻求IRB批准进行临床试验的系统。

DESCRIPTION (provided by applicant): Prostate cancer continues to be a significant health problem, being the second most common cause of cancer-related death among American men. Local recurrence of prostate cancer is the most frequently detected failure of primary treatment, which propels subsequent treatment regimens onto an aggressive orbit, with the primary objective being to stop the tumor from spreading, otherwise the patient will rapidly develop a life threatening condition. Studies have shown that thermal ablation is helpful in the management of locally recurrent prostate cancer, either as a sole modality or as a preadjuvant sensitizer for external beam radiotherapy. The applicants have demonstrated in-vivo on canine subjects that high intensity interstitial ultrasound (HIIU) is appropriate for highly conformal delivery of cancer-killing thermal dose to the prostate. As a natural continuation, a computer-controlled ultrasound image guided system is proposed for transrectal ultrasound image-guided delivery of treatment using high intensity interstitial ultrasound. The goals for Phase-I are to (1) develop a transrectal needle placement mechanism, (2) package an existing HIIU device in flexible needle, and (3) prove feasibility of the prototype device on ex-vivo animal models under image guidance. The goals for Phase-II are to design and implement a computer-integrated system, with advanced image guidance, visualization, planning, and real-time quality control functions. The unique attribute of the proposed system is that the physician can "see" the relationship of the ablator needle to the ideal thermal dose plan in realtime and quickly accommodate the spatial distribution of energy to compensate for any discrepancy. The most appealing element of this system is the prospect that the outcome of tissue ablation treatments would no longer depend decisively on the geometrical accuracy of device placement, because reasonable spatial inaccuracies could be safely compensated by the electronic spatial power distribution control built in the acoustic energy delivery mechanism. The resulting system will be tested on canine subjects and in a limited manner on human patients. The endpoint of the proposed research is a system for which IRB approval can be sought to conduct clinical trials.