Brain Tumor Therapy: Radio Surgery vs. MR-Guided Ablat;

描述（申请人提供）：每年有超过150，000例转移性脑肿瘤病例，预后约为6-8个月。传统的治疗选择，包括根治性手术，放射治疗和立体定向放射外科手术，往往伴随着全身副作用，住院时间长和发病率。由于肿瘤的位置，手术切除并不总是可能的。立体定向放射外科（SRS），虽然几乎是一个理想的方法微创治疗，运行的风险，急性放射毒性和放射性坏死，伴随着长期的质量效应，一般用类固醇治疗。我们建议的假设是，与SRS相比，MR引导和监测下的激光诱导间质热疗（LITT）可以成为脑转移瘤的有效治疗方法，治疗区域的局部控制良好，肿块效应的快速解决，减少类固醇摄入量和随后的生活质量因素。在本研究的两年内，将以前瞻性、随机方式对30例转移性肿瘤（< 3 cm）患者进行内部试点研究，其中一半患者将接受SRS治疗，另一半患者将接受MR引导的LITT治疗。具体目标1是开发在MR引导下使用激光消融脑肿瘤。使用新型温度敏感MRI序列和离线计算机监视器界面（此处开发），医生可以在近实时模式下查看消融的癌组织区域，而无需开放切除，因为它是由激光能量沉积创建的，提供了一种独特的非侵入性和精确的方法来监测和控制热分布的程度。具体目标2将通过MRI和其他测试在未来两年的长期随访来评估两种治疗方案的比较疗效。这些研究将产生结果变量，如病灶的局部控制、类固醇摄入和生活质量因素，允许基于不同预后因素进行多变量分析，以分层两个不同治疗组的疗效。另一种将通过一种技术治疗那些有治疗失败证据的人。未来将提出一项更大患者队列的II期试验，并根据该内部试点研究进行修改。PI和他的团队是开发介入MRI的先驱团队之一，IMRI中使用最广泛的仪器之一以其中之一（Lufkin针）命名。如果成功，这项技术将提供一个更小的侵入性和可能更有效的替代手术切除和立体定向放射外科手术，不仅转移性脑肿瘤，但在身体其他地方的肿瘤，并有可能显着改善癌症的管理一般。

DESCRIPTION (provided by applicant): There are over 150,000 cases of metastatic brain tumors annually, with a prognosis of about 6-8 months. Conventional treatment options, including radical surgery, radiation therapy and stereotactic radiosurgery, are often accompanied by systemic side effects, long hospital stays and morbidity. Surgical resection is not always possible because of tumor location. Stereotactic radiosurgery (SRS), while an almost ideal approach for minimally invasive therapy, runs the risk of acute radiation toxicity and radiation necrosis, accompanied by prolonged mass effect, treated generally by steroids. The hypothesis of our proposal is that laser-induced interstitial thermo-therapy (LITT) under MR-guidance and monitoring can be an effective treatment for cerebral metastases compared to SRS, with excellent local control of the treated area, fast resolution of mass effects, decreased steroid intake and subsequent quality-of-life factors. In the two years of this study, an internal pilot study will be carried out, in a prospective, randomized fashion, on 30 patients with metastatic tumors (< 3 cm), half of which will be treated with SRS and the other half with MR-guided LITT. Specific Aim 1 is to develop the use of laser to ablate brain tumors under MR guidance. Using novel temperature sensitive MRI sequences and an off-line computer monitor interface (developed here), the physician can view in a near real-time mode and without open resection, the zone of ablated cancer tissue as it is created by laser energy deposition, providing an unique noninvasive and precise method to monitor and control the extent of heat distribution. Specific Aim 2 will evaluate the comparative efficacy of the two treatment options by prolonged follow-up with MRI and other tests for the next two years. These investigations will yield outcome variables such as local control of lesion, steroid intake and quality-of-life factors, allowing a multivariate analysis based on different prognostic factors to stratify the efficacy of the two different treatment arms. The other will treat those with evidence of treatment failure by one technique. A future Phase II trial with a much larger patient cohort will be proposed with modifications dictated by this internal pilot study. The PI and his team have been one of the pioneering groups in the development of interventional MRI, with one of the most extensively used instruments utilized in the IMRI named after one of them (the Lufkin needle). If successful, this technique will offer a less invasive and possibly more effective alternative to surgical resection and stereotactic radiosurgery of not only metastatic brain tumors but to tumors elsewhere in the body and have the potential for significant improvement in cancer management in general.