Development of an innovative neurosurgical planning tool for awake craniotomy

摘要/摘要 脑肿瘤导致癌症发病率和死亡率不成比例。护理治疗标准 包括最大安全手术切除，其中手术切除范围 (EOR) 代表最相关 患者生存的预后因素。因为 EOR 取决于外科医生区分的能力 健康脑组织和肿瘤侵袭组织之间或邻近支持认知的大脑区域 功能，神经外科医生必须平衡临床目标和造成认知障碍。地面 促进这种区分的真相标准护理程序是清醒开颅手术，并使用直接脑图测绘 电刺激映射（DES）。了解实时手术中特定功能的位置 目标允许临床团队保护这些功能。这也是术前行为护理的标准 收集所有脑肿瘤患者的数据和脑部扫描。然而，没有基于证据的平台 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 了解去除特定体积的脑组织对未来认知功能的影响。 To fill this MindTrace Technologies, Inc. 正在开发一个基于云的软件平台，可在之前、期间和期间使用 神经外科手术后，以改进评估和选择最佳治疗计划的过程。 MindTrace 平台支持功能性脑图谱协议的管理（功能性脑图谱协议） 神经影像、DES 映射），以及行为和神经数据的预处理和共同注册 在清醒脑部手术期间优化脑部绘图有效性的服务。本次活动的总体目标 直接进入第二阶段SBIR提案是进一步完善先进的MindTrace原型软件平台和 在 IRB 的研究背景下部署它，以收集 4 个主要医学领域的前瞻性纵向数据 中心。完成这些目标将产生可商业化的产品，并奠定经验和基础 为开发基于人工智能的实时预测分析、大规模临床研究奠定了技术基础 试验和 FDA 批准。本文提出的方案设计基于 FDA 的书面反馈 （qSub会议）关于成功申请突破性设备所需的数据集参数 Designation.这项前瞻性研究生成的数据集将作为后续研究的实证基础 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）与因果证据相整合的公司 清醒脑部手术时产生的神经心理学表现及术后比较 术前神经心理表现。当前部署的平台的商业化 该提案代表了一个交钥匙软件产品，它集成了多个信息源，以实现 临床医生可以更有效地规划神经外科手术，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.