Interactive Image Guided Closed Loop Thermal Therapy

描述（由申请人提供）： 这个II期竞争继续研究项目的目标是完成一种新的磁共振成像引导微创治疗局灶性脑肿瘤的I期临床试验。在过去的四年中，BioTex开发了Visualase（r）热疗系统，用于治疗局部癌症，该系统使用温度敏感的磁共振成像（MRI）数据来精确控制激光能量的输送和组织破坏的程度。 该系统目前的主要目标应用是脑中的小病灶继发性或转移性肿瘤和前列腺中的局部癌症。次要应用包括治疗椎体转移性病变和不可切除的肝脏肿瘤。今年美国将诊断出大约40，900例原发性脑肿瘤和超过100，000例转移性脑肿瘤。此外，190，000名美国男性将被诊断出患有前列腺癌，超过30，000人将死于这种疾病。在今年将被诊断患有癌症的130万患者中（不包括非黑色素瘤皮肤癌），大约5-10%将在脊柱中发展有问题的继发性转移性肿瘤，这将需要干预。 在拟议研究的第一年，我们将参与美国食品药品监督管理局（FDA）批准研究器械豁免（IDE）所需的临床前研究和管理活动。在第二年和第三年，我们将进行一项I期临床试验，以探索Visualase系统治疗小病灶转移性脑肿瘤患者的安全性和实用性，特别是那些深位或无法手术的患者。在本研究结束时，我们将探索脑内激光疗法治疗小的局灶性转移性病变的临床可行性和安全性，我们将把Visualase系统和组件提升到适合510（k）上市前批准的功能和生产水平。这种立体定向激光热疗法与实时MRI的结合将促进诊断和治疗环境的前所未有的整合。

DESCRIPTION (provided by applicant): The goal of this Phase II Competing Continuation research project is to complete the Phase I clinical trial of a new magnetic resonance imaging guided minimally invasive treatment for focal brain tumors. Over the past four years, BioTex has developed the Visualase(r) thermal therapy system for treatment of localized cancers by using temperature-sensitive magnetic resonance imaging (MRI) data to precisely control the delivery of laser energy and the extent of tissue destruction. The current primary target applications for this system are small focal secondary or metastatic tumors in the brain and localized cancer in the prostate. Secondary applications include treatment of metastatic lesions in vertebral bodies, and unresectable liver tumors. Approximately 40,900 primary brain tumors and over 100,000 metastatic brain tumors will be diagnosed this year in the U.S. Additionally, 190,000 American men will be diagnosed with prostate cancer, and over 30,000 will die from the disease. Of the 1.3 million patients who will be diagnosed with cancer this year (excluding nonmelanoma skin cancers), approximately 5-10% will develop problematic secondary metastatic tumors in the spine which will require intervention. In the first year of the proposed study, we will engage in pre-clinical studies and administrative activities required for U.S. Food and Drug Administration (FDA) approval of an investigative device exemption (IDE). In the second and third years, we will conduct a Phase I clinical trial to explore the safety and utility of the Visualase system for treatment of patients will small focal metastatic brain tumors, particularly those which are deep-seated or otherwise inoperable. At the end of this study, we will have explored the clinical feasibility and safety of intracerebral laser therapy for treatment of small focal metastatic lesions, and we will have advanced the Visualase system and components to a feature and production level appropriate for 510(k) pre-market approval. This combination of stereotactic laser thermal therapy with real-time MRI will facilitate an unprecedented integration of the diagnostic and therapeutic environments.