Focal Laser Ablation of Prostate Cancer using MR/US Fusion

项目摘要 前列腺癌(CAP)是美国男性最常见的内科恶性肿瘤。超过18万例新病例和 预计2016年将有2.6万人死于癌症，使其成为男性癌症死亡的第二大常见原因。焦点 治疗，中等风险帽男性的一种新选择-据NCI估计，这一群体包括 每年新增病例6万例--已成为人们极感兴趣的话题。焦距的各种能量 在治疗方面，激光消融(FLA)之所以引人注目，是因为它的精确度，因为它提供了 门诊治疗，不需要全身麻醉或手术室。通常在以下情况下执行 在MRI的直接引导下，FLA能够通过热疗产生明确的凝固性坏死区 在前列腺内，不损害邻近组织，也不会导致失禁或勃起功能障碍。 CAP焦点治疗的关键是靶向活检，这是我们从2009年开始的一项程序，在 之前的学术-工业R01拨款。在靶向活检中，多参数磁共振用于成像， ARTEMIS设备用于将存储的磁共振图像与实时超声融合。然后在临床上进行活组织检查 对准核磁共振显示的可疑区域。大约有2500个这样的程序已经在 加州大学洛杉矶分校，是现存最丰富的经验之一，因此我们的团队获得了相当多的专业知识 局部前列腺癌的活检针。 利用从活检计划中获得的知识，我们对8名男性在钻孔内，即在MRI管内，使用 MRI直接引导定位，MR测温监护。钻孔内治疗被证明是安全的。 而且可行，但冗长、昂贵、资源密集型，缺乏广泛采用的潜力。 因此，我们将这一过程引入临床，使用MR/US融合进行指导和直接热疗。 用于温度监测的探头。在FDA的IDE下进行的临床手术(N=10)产生了 结果与钻孔手术相似，但要简单得多，速度更快，而且可能更便宜。 我们建议在大量初步经验的基础上创建和测试一项技术，该技术将允许 广泛采用FLA作为CAP。将这一想法转化为临床实践取决于(A)MRI/US Fusion用于指导，我们已经有专业知识，(B)用于前列腺内温度的热探头 监测，将由合作伙伴LumaSense制造，以及(C)一种新的超声探头，允许可视化 激光和热探头，由合作伙伴MDMedtech制造。虽然不是官方合作伙伴，但美敦力 通过捐赠Visualase系统来支持这个项目，通过捐赠超声波机来支持日立。 工作将从创建和测试每个系统组件开始，然后进行多机构验证 对中等风险上限男性的研究(加州大学洛杉矶分校/斯坦福/康奈尔大学)，在就业前和目标随访中 活组织检查以证明疗效。该项目的成功完成将导致安全、有效、经济的 前列腺癌临床治疗系统每年适用于数以万计的男性。

Project Summary Prostate cancer (CaP) is the commonest internal malignancy in U.S. men. More than 180,000 new cases and 26,000 deaths are expected during 2016, making it the 2nd most common cause of cancer death in men. Focal therapy, a new alternative for men with intermediate risk CaP – a group estimated by NCI to comprise as many as 60,000 new cases every year – has become a subject of keen interest. Of the various energies for focal therapy, laser ablation (FLA) is compelling because of its precision and because it offers the potential of an outpatient treatment without need for general anesthesia or an operating room. Ordinarily performed under direct MRI guidance, FLA is capable of producing a well-defined zone of coagulation necrosis via hyperthermia within the prostate without damage to adjacent tissue and without causing incontinence or erectile dysfunction. The linchpin of CaP focal therapy is targeted biopsy, a procedure that we started in 2009 and developed under a previous Academic-Industrial R01 grant. In targeted biopsy, multi-parametric MRI is used for imaging and the Artemis device is used for fusing stored MR images with real-time ultrasound. Biopsy in the clinic can then be directed at suspicious regions seen on MRI. Approximately 2500 such procedures have been performed at UCLA, among the largest experience extant, and thus our team has gained considerable expertise placing biopsy needles into localized prostate cancers. Using knowledge from the biopsy program, we performed FLA on 8 men in-bore, i.e., inside an MRI tube, using direct MRI guidance for localization and MR thermometry for monitoring. The in-bore treatments proved safe and feasible, but lengthy, expensive, and resource-intensive, lacking the potential for widespread adoption. Therefore, we brought the procedure into the clinic, using MR/US fusion for guidance and direct thermal probes for temperature monitoring. The clinic procedures (N=10), performed under an IDE from FDA, yielded results like the in-bore procedures, but were much simpler, quicker, and potentially less expensive. We propose to build upon a substantial preliminary experience to create and test a technology that would allow widespread adoption of FLA for CaP. Translation of the idea into clinical practice depends upon (a) MRI/US fusion for guidance, with which we already have expertise, (b) thermal probes for intra-prostatic temperature monitoring, to be fabricated by partner LumaSense, and (c) a novel ultrasound probe to allow visualization of both laser and thermal probe, to be fabricated by partner MDMedtech. While not official partners, Medtronic has endorsed this project by donating the Visualase system and Hitachi by donating the ultrasound machine. Work would begin with creation and testing of each system component, followed by a multi-institution validation study (UCLA/Stanford/Cornell) in men with intermediate-risk CaP, employing before and follow-up targeted biopsy to prove efficacy. Successful completion of the project would lead to a safe, effective, economical system for clinic-based treatment of prostate cancer applicable to tens of thousands of men every year.