Development of an innovative neurosurgical planning tool for awake craniotomy

总结/摘要 脑肿瘤导致不成比例的癌症发病率和死亡率。标准护理治疗 包括最大安全手术切除，手术切除范围（EOR）代表最相关 患者生存的预后因素。因为EOR取决于外科医生的能力， 健康的脑组织和肿瘤侵入的组织之间的关系， 神经外科医生必须平衡临床目标和引起认知障碍。地面 促进这种区分的真实标准护理程序是清醒开颅术，使用直接脑成像技术进行脑标测。 电刺激标测（DES）。了解特定功能在实时手术中的位置 目标允许临床团队保护这些功能。它也是术前行为障碍的标准治疗方法。 收集所有脑瘤患者的数据和脑部扫描。然而，没有一个基于证据的平台 它允许临床团队选择最敏感的任务来绘制和测量给定的大脑区域，或者 理解移除特定体积的脑组织对未来认知功能的影响。填补这一 Gap，MindTrace Technologies，Inc.正在开发一个基于云的软件平台， 在神经外科手术后，以改善评估和选择最佳治疗计划的过程。 MindTrace平台支持管理功能性大脑映射协议（功能性 神经成像，DES映射），以及预处理和共同登记的行为和神经数据在 在清醒脑外科手术期间优化脑映射的有效性的服务。这个项目的总体目标是 直接到第二阶段SBIR建议是进一步改进先进的原型MindTrace软件平台， 在研究性研究的背景下将其部署在IRB下，以收集4个主要医疗机构的前瞻性纵向数据 中心.这些目标的完成将产生可商业化的产品，并奠定经验和 为开发基于人工智能的实时预测分析奠定了技术基础， 试验和FDA批准本文提出的方案设计基于FDA的书面反馈 (qSub关于成功申请突破性器械所需的数据集参数 名称.本前瞻性研究生成的数据集将作为后续研究的经验基础。 AI/ML预测分析的技术开发。 MindTrace是唯一一家将相关数据（行为，功能性MRI）与因果证据相结合的公司 在清醒的脑手术中产生的，以及术后神经心理学表现的比较 术前神经心理学表现。在现有的基础设施内部署的平台的商业化 提案代表了一个交钥匙软件产品，它集成了多种信息源， 临床医生更有效地计划神经外科手术，以支持最佳的术后生活质量。

SUMMARY/ABSTRACT Brain tumors result in a disproportionate rate of cancer morbidity and mortality. Standard of care treatment includes maximal safe surgical resection, with extent of surgical resection (EOR) representing the most relevant prognostic factor for patient survival. Because EOR is dependent on the surgeon’s capability to distinguish between healthy brain tissue and tumor-invaded tissue in or adjacent to brain areas that support cognitive function, the neurosurgeon must balance clinical objectives against causing cognitive impairments. The ground truth standard-of-care procedure to facilitate this distinction is awake craniotomy with brain mapping using direct electrical stimulation mapping (DES). Knowing the location of specific functions with respect to real-time surgical targets allows the clinical team to protect those functions. It is also standard of care for pre-operative behavioral data and brain scans to be collected on all brain tumor patients. However, there is no evidenced-based platform that allows clinical teams to choose the most sensitive task to map and measure a given brain region, or to understand the implications for future cognitive function of removing a specific volume of brain tissue. To fill this gap, MindTrace Technologies, Inc. is developing a cloud-based software platform to be used before, during, and after a neurosurgical procedure to improve the process of evaluating and choosing an optimal treatment plan. The MindTrace platform supports the administration of functional brain mapping protocols (functional neuroimaging, DES mapping), and the pre-processing and co-registration of behavioral and neural data in the service of optimizing the effectiveness of brain mapping during awake brain surgery. The overall goal of this Direct to Phase II SBIR proposal is to further improve the advanced prototype MindTrace software platform and deploy it under IRB in the context of a research study to collect prospective longitudinal data at 4 major medical centers. Completion of these Aims will result in a commercializable product and lay the empirical and technological foundation for the development of real-time AI-based predictive analytics, a large-scale clinical trial, and FDA clearance. The design of the protocol proposed herein is based on written feedback from FDA (qSub meeting) regarding the parameters of a dataset needed for successfully apply for Breakthrough Device Designation. The dataset to be generated by this prospective study will be the empirical basis for follow on technology development in AI/ML predictive analytics. MindTrace is the only company to integrate correlational data (behavior, functional MRI) with the causal evidence generated during awake brain surgery, and the comparison of post-operative neuropsychological performance to preoperative neuropsychological performance. Commercialization of the platform deployed within the current proposal represents a turn-key software product that integrates multiple sources of information to enable clinicians to plan neurosurgery more effectively in support of the best postoperative quality-of-life.