Interactive Image Guided Closed Loop Thermal Therapy

交互式图像引导闭环热疗

• 批准号: 6883815
• 负责人: ROGER J MCNICHOLS
• 金额: $ 61.46万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-07-01 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883815
• 关键词: bioimaging /biomedical imaging; biomedical equipment development; brain neoplasms; clinical biomedical equipment; clinical research; clinical trial phase I; disease /disorder model; dogs; human subject; human therapy evaluation; image guided surgery /therapy; laboratory rat; laser therapy; magnetic resonance imaging; neoplasm /cancer radiation therapy; neoplasm /cancer transplantation; neurosurgery; nonhuman therapy evaluation; photocoagulation therapy; prostate neoplasms; temperature; therapy design /development

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.

描述（由申请人提供）： 该二期竞争性延续研究项目的目标是完成一种新的磁共振成像引导的局灶性脑肿瘤微创治疗的一期临床试验。在过去的四年里，BioTex 开发了 Visualase(r) 热治疗系统，通过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传递和组织破坏的程度，用于治疗局部癌症。 该系统目前的主要目标应用是大脑中的小局灶性继发性或转移性肿瘤以及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，美国将诊断出约 40,900 例原发性脑肿瘤和超过 100,000 例转移性脑肿瘤。此外，还将有 190,000 名美国男性被诊断出患有前列腺癌，超过 30,000 人将死于该病。在今年将被诊断患有癌症的 130 万名患者中（不包括非黑色素瘤皮肤癌），大约 5-10% 的患者将在脊柱中出现有问题的继发性转移性肿瘤，需要进行干预。 在拟议研究的第一年，我们将从事美国食品和药物管理局 (FDA) 批准研究设备豁免 (IDE) 所需的临床前研究和行政活动。在第二年和第三年，我们将进行一期临床试验，以探索 Visualase 系统治疗小灶性转移性脑肿瘤患者的安全性和实用性，特别是那些深部或无法手术的患者。在本研究结束时，我们将探索脑内激光疗法治疗小灶性转移性病变的临床可行性和安全性，并且我们将 Visualase 系统和组件提升到适合 510(k) 的功能和生产水平上市前批准。立体定向激光热疗与实时 MRI 的结合将促进诊断和治疗环境的前所未有的整合。