Transrectal Ultrasound Ablation Of The Prostate

经直肠前列腺超声消融术

• 批准号: 6840292
• 负责人: GABOR FICHTINGER
• 金额: $ 16.47万
• 依托单位: ACOUSTIC MEDSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6840292
• 关键词: bioimaging /biomedical imaging; biomedical equipment development; clinical research; dogs; human subject; image guided surgery /therapy; patient oriented research; prostate; prostate neoplasms; prostate surgery; surgery material /equipment; ultrasound therapy

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.

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检测到的主要治疗失败，其将随后的治疗方案推进到侵略性轨道上，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病症。研究表明，热消融有助于局部复发性前列腺癌的管理，无论是作为唯一的方式或作为外部束放射治疗的前辅助增敏剂。申请人已经在犬受试者体内证明，高强度间质超声（HIIU）适合于将癌症杀伤热剂量高度适形地递送到前列腺。作为一个自然的延续，提出了一种计算机控制的超声图像引导系统，用于使用高强度组织间超声进行经直肠超声图像引导的治疗递送。 第一阶段的目标是（1）开发经直肠穿刺针放置机制，（2）将现有HIIU器械包装在柔性穿刺针中，（3）在图像引导下证明原型器械在离体动物模型上的可行性。 第二阶段的目标是设计和实现一个计算机集成系统，具有先进的图像引导、可视化、规划和实时质量控制功能。所提出的系统的独特属性是，医生可以实时“看到”消融针与理想热剂量计划的关系，并快速适应能量的空间分布，以补偿任何差异。该系统最吸引人的元素是组织消融治疗的结果将不再决定性地取决于装置放置的几何精度的前景，因为合理的空间不准确性可以通过内置于声能输送机构中的电子空间功率分布控制来安全地补偿。 所产生的系统将在犬受试者上进行测试，并以有限的方式在人类患者上进行测试。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。