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

描述（申请人提供）：每年有超过15万例转移性脑肿瘤，预后约为6-8个月。常规治疗方案，包括根治性手术、放射治疗和立体定向放射手术，往往伴随着全身副作用、长期住院和发病率。由于肿瘤的位置，手术切除并不总是可行的。立体定向放射外科（SRS）虽然是一种几乎理想的微创治疗方法，但存在急性放射毒性和放射性坏死的风险，并伴有长期的肿块效应，通常使用类固醇治疗。我们建议的假设是，与SRS相比，在mr指导和监测下的激光诱导间质热疗法（LITT）可以有效治疗脑转移瘤，具有良好的局部控制治疗区域，快速解决肿块效应，减少类固醇摄入量和随后的生活质量因素。在为期两年的研究中，将对30例转移性肿瘤（< 3cm）患者进行前瞻性、随机化的内部先导研究，其中一半患者将接受SRS治疗，另一半患者将接受mr引导下的LITT治疗。具体目标1是发展在MR指导下使用激光消融脑肿瘤。使用新型的温度敏感MRI序列和离线计算机监视器接口（在这里开发），医生可以在接近实时的模式下查看激光能量沉积形成的消融癌组织区域，而无需开放切除，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。特异性目标2将在未来两年通过MRI和其他测试的长期随访来评估两种治疗方案的相对疗效。这些调查将产生结果变量，如病灶局部控制、类固醇摄入和生活质量因素，允许基于不同预后因素的多变量分析，以对两种不同治疗组的疗效进行分层。另一个将用一种技术治疗那些有治疗失败证据的人。未来的二期临床试验将纳入更大的患者群体，并根据该内部试点研究进行修改。PI和他的团队一直是开发介入性MRI的先驱团体之一，IMRI中使用最广泛的仪器之一（Lufkin针）以他们之一命名。如果成功，这项技术将为转移性脑肿瘤以及身体其他部位的肿瘤提供一种侵入性更小、可能更有效的手术切除和立体定向放射外科手术的替代方法，并有可能在总体上显著改善癌症管理。

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.