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

描述(申请人提供)：每年有超过15万例脑转移瘤，预后约为6-8个月。传统的治疗方法，包括根治性手术、放射治疗和立体定向放射外科，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行的。立体定向放射外科(SRS)虽然是一种近乎理想的微创治疗方法，但存在急性辐射毒性和辐射坏死的风险，并伴有长期的质量效应，一般采用类固醇治疗。我们的假设是，在MR引导和监测下的激光诱导间质热疗(LIT)与SRS相比，可以有效地治疗脑转移瘤，具有良好的局部控制性，肿块效应迅速消失，类固醇摄入量减少和随后的生活质量因素。在这项研究的两年中，将以前瞻性、随机的方式对30名转移性肿瘤患者进行内部先导研究，其中一半将接受SRS治疗，另一半将接受MR引导的LITT治疗。具体目标1是开发在磁共振引导下使用激光消融脑肿瘤。使用新的温度敏感型MRI序列和离线计算机监控界面(在此开发)，医生可以在近乎实时的模式下查看消融肿瘤组织的区域，因为它是由激光能量沉积形成的，提供了一种独特的非侵入性和精确的方法来监控热分布的程度。具体目标2将在未来两年通过核磁共振成像和其他测试的长期随访来评估这两种治疗方案的比较疗效。这些研究将产生结果变量，如局部病变控制、类固醇摄入量和生活质量因素，使基于不同预后因素的多变量分析能够对两种不同治疗方案的疗效进行分层。另一种是通过一种技术来治疗那些有治疗失败证据的人。未来的第二阶段试验将有更大的患者队列，并将根据这项内部先导性研究进行修改。PI和他的团队一直是开发介入性MRI的先驱团队之一，IMRI中使用最广泛的工具之一以其中之一(Lufkin针)命名。如果成功，这项技术将提供一种侵入性更小、可能更有效的替代手术切除和立体定向放射外科手术，不仅是对脑转移瘤，而且是对身体其他部位的肿瘤，并有可能在总体上显著改善癌症治疗。

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.