Focal Laser Ablation of Prostate Cancer using MR/US Fusion

项目摘要 前列腺癌（CaP）是美国男性中最常见的内部恶性肿瘤。超过180，000个新病例， 预计2016年将有26，000人死亡，使其成为男性癌症死亡的第二大常见原因。焦 治疗，一个新的替代男性中度风险CaP -一组估计由NCI，包括尽可能多的 由于每年有六万宗新个案，已成为一个备受关注的课题。各种能量的焦点 激光消融术（弗拉）是引人注目的，因为它的精度，因为它提供了一个潜在的 无需全身麻醉或手术室的门诊治疗。通常在以下情况下执行 在MRI直接引导下，弗拉能够通过高温产生明确的凝固性坏死区 在前列腺内，而不损伤邻近组织，并且不引起失禁或勃起功能障碍。 CaP局部治疗的关键是靶向活检，这是我们于2009年开始的一项手术， 以前的学术-工业R 01资助。在靶向活检中，多参数MRI用于成像， Artemis设备用于将存储的MR图像与实时超声融合。然后在诊所进行活检， 针对MRI上的可疑区域。大约2500例此类手术已在 加州大学洛杉矶分校，其中最大的经验现存，因此，我们的团队已经获得了相当多的专业知识， 活检针插入局部前列腺癌。 利用活检程序的知识，我们对8名男性进行了孔内弗拉，即，在核磁共振成像管中， 用于定位的直接MRI引导和用于监测的MR测温。钻孔治疗被证明是安全的 并且可行，但是冗长、昂贵和资源密集，缺乏广泛采用的潜力。 因此，我们将该手术引入临床，使用MR/US融合进行指导，并直接热疗。 用于温度监测的探头。根据FDA的IDE进行的临床程序（N=10）产生了 结果类似于孔内手术，但更简单、更快，而且可能更便宜。 我们建议建立在大量的初步经验，以创建和测试一种技术， 广泛采用弗拉用于CaP。将这一想法转化为临床实践取决于（a）MRI/US 用于引导的融合，我们已经具有这方面的专业知识，（B）用于前列腺内温度的热探头 监测，将由合作伙伴LumaSense制造，和（c）一种新型的超声探头，允许可视化 激光和热探头，由合作伙伴MDMedtech制造。美敦力虽然不是官方合作伙伴， 通过捐赠Visualase系统和捐赠超声波机器，日立公司支持了该项目。 工作将从创建和测试每个系统组件开始开始，然后进行多机构验证 一项在中度风险CaP男性中进行的研究（UCLA/斯坦福大学/康奈尔大学），采用了针对性的术前和随访 活检以证明疗效。该项目的成功完成将导致安全，有效，经济 前列腺癌的临床治疗系统，每年适用于成千上万的男性。

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.