Enabling Technologies for MRI-Guided Prostate Interventions

描述（由申请人提供）：我们在该提案中的目标是生产一种FDA批准的图像引导平台，用于MRI或超声，从基线成像到前列腺活检依次用于前列腺癌的诊断和治疗（近距离放射治疗）。如今，前列腺癌最常见的诊断方法，即经直肠超声（TRUS）引导活检，在很大一部分时间内会错过癌症。因此，我们建议开发一种MR/US成像平台，该平台在两种干预中使用机器人辅助进行精确的针放置：使用MR或TRUS组合的经会阴活检引导和MR引导近距离放射治疗，旨在更好地识别，靶向和治疗癌症，副作用更少。我们的方法具有在近距离放射治疗过程中动态、精确和定量评价活检针或针和源（种子）位置和目标剂量的能力。我们相信这些能力可以提高整体活检率和/或治疗质量（改善剂量，降低发病率和毒性）。在我们的过程中，癌症治疗将受益于活检确认的肿瘤位置，允许剂量递增和基于癌症位置的组织学映射修改治疗计划。已经开发出具有软件程序的第一代和第二代设备。在下一个周期中，我们将开发MR/US配准算法和MR/US组织分类，以将我们的方法从MR扩展到更普遍的US模式。我们将重新设计和验证一个远程驱动的主从机器人与触觉反馈活检和近距离放射治疗过程中的针放置。医生将通过操作孔旁边的“主”机器人接口完全控制MRI扫描仪孔中的“从”机器人，以便与TRUS或MR引导的手动方法相比，在活检和近距离放射治疗中更精确地放置针。一个主/从机器人设备，基于我们的第一个周期的工作，将在布里格姆妇女医院的新的图像引导治疗套件，AMIGO，其中包含一个3 T宽孔磁铁。3 T MRI技术已成为Brigham所有MR成像方案的支柱，在第一个周期中，我们已经建立了基于3 T模板的经会阴活检程序。除了支持性的初步数据外，我们已经做好了向前迈进的充分准备，因为我们已经组建了一个拥有成功完成研究所有阶段所需专业知识的团队。我们的长期目标，这超出了这个建议，是建立一个平台，精确的针放置到图像定义的病变，使图像引导的分子诊断。通过这一点，我们的意思是，最终任何成像研究，传统的或分子（例如PET与C- 11示踪剂），可以注册与我们在这里提出的技术，并使用我们的机器人方法采样。为了实现这一目标，我们将与Dana Farber-Harvard癌症中心（NCI中心）的病理学核心合作，开始研究与前列腺病理基因组学相关的表型（成像）。

DESCRIPTION (provided by applicant): Our goal in this proposal is to produce an FDA-approved image-guidance platform for use with MRI or ultrasound to be used sequentially from baseline imaging through prostate biopsy for diagnosis and treatment (brachytherapy) of prostate cancer. Today, the most common diagnostic method for prostate cancer, transrectal ultrasound (TRUS)-guided biopsy, misses cancer a significant percentage of the time. We, therefore, propose to develop an MR/US imaging platform that uses robotic assistance for precise needle placement in two interventions: transperineal biopsy-guided using either a combination of MR or TRUS and MR-guided brachytherapy with an aim to better identify, target, and treat cancer with fewer side effects. Our approach has the capabilities for dynamic, precise, and quantitative evaluation of biopsy needle or needle and source (seed) position and target dosimetry during the course of a brachytherapy procedure. We believe these capabilities can improve overall biopsy yield and/or quality of therapy (improved dosage, reduced morbidity and toxicity). In our process, cancer treatment will benefit from biopsy-confirmed tumor locations that allow for dose escalation and modification of a treatment plan based upon histological mapping of cancer locations. First and second generation devices with software programs have already been developed. In the next cycle, we will develop MR/US registration algorithms and MR/US tissue classification to extend our approaches beyond MR to the more ubiquitous modality of US. We will re-design and validate a remotely actuated master-slave robotic with haptic feedback for needle placement during biopsy and brachytherapy. A physician will fully control the "slave" robot in the bore of the MRI scanner by operating a "master" robotic interface next to the bore for more precise needle placement in biopsies and brachytherapy compared to TRUS- or MR-guided manual approaches. A master/slave robotic device, based upon our first cycle work, will be at the Brigham and Women's Hospital's new image guided therapy suite, the AMIGO, that contains a 3T wide bore magnet. 3T MRI techniques have become a mainstay of all MR imaging protocols at the Brigham, and in the first cycle we have established a 3T template-based transperineal biopsy program. In addition to our supportive preliminary data, we are well prepared to move forward because we have assembled a team with the expertise needed to successfully complete all phases of the research. Our longer term goal, which extends beyond this proposal, is to establish a platform for precise needle placement into image-defined lesions to allow for image-guided molecular diagnostics. By this we mean, ultimately any imaging study, traditional or molecular (e.g PET with C- 11 tracers), can be registered with the techniques we propose here and sampled using our robotic approach. In pursuit of this we would collaborate with the Pathology Core at the Dana Farber-Harvard Cancer Center (NCI center) to begin investigating the phenotypic (imaging) correlates with prostate pathological genomics.