Validation and Translation of MasSpec Pen Technology for Intraoperative Evaluation of Non-small Cell Lung Cancer

MasSpec Pen 技术在非小细胞肺癌术中评估中的验证和转化

• 批准号: 10753977
• 负责人: Bryan Michael Burt
• 金额: $ 60.16万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-02 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10753977
• 关键词: Adenocarcinoma; Biopsy; Cancer Detection; Cancer Etiology; Caring; Cessation of life; Clinical; Clinical Research; Data; Decision Making; Detection; Development; Devices; Diagnosis; Diagnostic; Disease; Evaluation; Excision; Freezing; Frequencies; Frozen Sections; Hand; Hematoxylin and Eosin Staining Method; Histologic; Histopathology; Lobectomy; Lung; Lung nodule; Lymph Node Dissections; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of pancreas; Mass Spectrum Analysis; Medicine; Metals; Molecular; Molecular Diagnosis; Morphology; Non-Small-Cell Lung Carcinoma; Normal tissue morphology; Observational Study; Operating Rooms; Operative Surgical Procedures; Pathologist; Patient Care; Patient-Focused Outcomes; Patients; Performance; Procedures; Process; Reporting; Reproducibility; Retrospective Studies; Robotics; Scientist; Segmental Mastectomy; Side; Slide; Specificity; Specimen; Squamous Cell; Stains; Sterility; Structure of parenchyma of lung; Surgeon; Surgical complication; Surgical margins; System; Techniques; Technology; Testing; Thoracic Surgeon; Time; Tissue Banks; Tissue Sample; Tissues; Translating; Translations; United States; Validation; Water; accurate diagnosis; cancer diagnosis; cancer subtypes; cancer surgery; clinical care; clinical decision-making; college; handheld equipment; improved; improved outcome; in vivo; in vivo evaluation; innovation; innovative technologies; lung cancer screening; malignant breast neoplasm; minimally invasive; new technology; next generation; operation; prospective; prototype; rapid diagnosis; research and development; seal; specific biomarkers; standard of care; surgical risk; technology validation; tumor; tumor diagnosis

SUMMARY Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the United States for which surgery remains a critical treatment option. The appropriate extent of resection for NSCLC is highly dependent on intra-operative decision-making. Specifically, the diagnosis of NSCLC is often determined intra-operatively by a limited resection of a suspicious pulmonary nodule, and intraoperative diagnosis is required before proceeding to a larger, cancer-specific resection during the same procedure. Further, intraoperative evaluation of resection margins is required in NSCLC surgeries to assure complete cancer removal before leaving the operating room (OR). Thus, the ability to accurately diagnose NSCLC and determine surgical margins in the OR is critical in the care for patients with NSCLC. However, the current technology used for intraoperative evaluation of NSCLC diagnosis and margins is frozen section analysis, a century-old technique that is labor-intensive and prone to error. Frozen section analysis also extends operative time, subjecting patients to increased risks of surgical complications. New technologies that can provide surgeons with the ability to rapidly and accurately diagnose NSCLC in the OR and evaluate surgical margins with high accuracy are critically needed to improve surgical care and outcomes for patients. We have reported the development of an innovative technology, the MasSpec Pen (MSPen), for rapid and non-destructive diagnosis of cancer tissues. The MSPen deploys a single droplet of water to gently extract molecules from tissues, which are then analyzed by mass spectrometry (MS) and statistical classifiers to provide diagnosis in seconds. We have demonstrated that the MSPen can accurately diagnose NSCLC using banked tissues with 97% accuracy. We have also shown that the MSPen system can be translated to the OR for use by surgeons for rapid in vivo and ex vivo tissue analysis. Through a collaborative partnership between academic scientists and surgeons at Baylor College of Medicine and the R&D team at MSPen Technologies Inc., we now propose to refine and validate the MSPen for intraoperative diagnosis and surgical margin evaluation in NSCLC. Our objective is to optimize and translate new MSPen technology for NSCLC detection, test its functionality, and validate its performance in the OR setting, thus delivering a potentially improved platform for intraoperative lung tissue analysis to surgeons - the end users. Our specific aims are: Aim 1. Optimize the MSPen Technology for intraoperative use in NSCLC operations. We will develop a next-gen MSPen platform for use in open and robotic NSCLC surgeries; Aim 2. Validate the MSPen for NSCLC diagnosis. We will conduct a prospective observational study allowing thoracic surgeons to validate the technology for NSCLC diagnosis in the OR; Aim 3. Validate the MSPen for intraoperative surgical margin evaluation in NSCLC. We will validate the MSPen technology for surgical margin evaluation in vivo and ex vivo, including the most representative tissue margins that are currently disregarded in clinical care. Our propose has the potential to offer transformative benefits to surgeons in advancing the surgical standard of care for patients with lung cancer.

概括 非小细胞肺癌 (NSCLC) 是美国癌症相关死亡的主要原因 手术仍然是一个重要的治疗选择。 NSCLC 的适当切除范围高度依赖于 关于术中决策。具体而言，NSCLC 的诊断通常是在手术中确定的 通过有限切除可疑的肺结节，并在手术前进行术中诊断 在同一手术中进行更大的癌症特异性切除术。此外，术中评估 非小细胞肺癌手术中需要达到一定的切除边缘，以确保在离开手术室之前完全切除癌症 手术室（OR）。因此，能够准确诊断 NSCLC 并确定 OR 中的手术切缘 对于 NSCLC 患者的护理至关重要。然而，目前用于术中评估的技术 NSCLC 诊断和切缘的主要方法是冰冻切片分析，这是一种具有百年历史的技术，需要大量的人力和时间 容易出错。冰冻切片分析还会延长手术时间，使患者面临更大的风险 手术并发症。新技术可以为外科医生提供快速、准确地 迫切需要在手术室诊断 NSCLC 并高精度评估手术切缘，以改善 患者的手术护理和结果。我们报道了一项创新技术的发展， MasSpec Pen (MSPen)，用于快速、无损地诊断癌症组织。 MSPen 部署单个 水滴轻轻地从组织中提取分子，然后通过质谱 (MS) 进行分析 和统计分类器可在几秒钟内提供诊断。我们已经证明 MSPen 可以准确地 使用库存组织诊断 NSCLC 的准确率高达 97%。我们还表明，MSPen 系统可以 被翻译成手术室供外科医生用于快速体内和离体组织分析。通过协作 贝勒医学院的学术科学家和外科医生与研发团队之间的合作 MSPen Technologies Inc.，我们现在建议改进和验证用于术中诊断和治疗的 MSPen NSCLC 的手术切缘评估。我们的目标是优化和转化新的 MSPen 技术 NSCLC 检测、测试其功能并验证其在 OR 设置中的性能，从而提供潜在的 为外科医生（最终用户）提供改进的术中肺组织分析平台。我们的具体目标是： 目标 1. 优化MSPen技术在NSCLC手术中的术中使用。我们将开发下一代 MSPen 平台用于开放式和机器人 NSCLC 手术；目标 2. 验证 MSPen 用于 NSCLC 诊断。 我们将进行一项前瞻性观察研究，让胸外科医生验证该技术 手术室诊断非小细胞肺癌；目标 3. 验证 MSPen 用于 NSCLC 术中手术切缘评估。 我们将验证 MSPen 技术用于体内和离体手术切缘评估，包括大多数 目前在临床护理中被忽视的代表性组织边缘。我们的建议有潜力 为外科医生提高肺癌患者的手术护理标准提供变革性的好处。