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; 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）是美国与癌症相关死亡的主要原因 手术仍然是一个关键的治疗选择。 NSCLC的适当切除范围高度依赖 关于术中决策。具体而言，通常在术中确定NSCLC的诊断 通过对可疑肺结节的有限切除，需要术中诊断 在同一过程中进行更大的，癌症特异性切除术。此外，术中评估 NSCLC手术中需要切除率的缘 手术室（OR）。因此，能够准确诊断NSCLC并确定OR中的手术边缘的能力 NSCLC患者的护理至关重要。但是，当前用于术中评估的技术 NSCLC诊断和边缘是冷冻部分分析，这是一种具有劳动密集型和 容易出错。冷冻部分分析还延长了手术时间，使患者的风险增加 手术并发症。可以为外科医生提供快速，准确的能力的新技术 在OR中诊断NSCLC并以高精度评估手术边缘需要高度改进 患者的手术护理和结局。我们报告了创新技术的发展， MassPec Pen（MSPEN），用于对癌组织的快速和非破坏性诊断。 Mspen部署了一个 水滴从组织中轻轻提取分子，然后通过质谱法（MS）分析它们 和统计分类器以在几秒钟内提供诊断。我们已经证明了Mspen可以准确 使用银行组织诊断NSCLC的精度为97％。我们还表明，MSPEN系统可以 被翻译成外科医生在体内快速和体内组织分析中使用的OR。通过协作 贝勒医学院的学术科学家与外科医生与研发团队之间的伙伴关系 Mspen Technologies Inc.，我们现在建议改进和验证MSPEN术中诊断和 NSCLC中的手术边缘评估。我们的目标是优化和翻译新的MSPEN技术 NSCLC检测，测试其功能并验证其在或设置中的性能，从而提供潜在的 改进了对外科医生 - 最终用户进行术中肺组织分析的平台。我们的具体目标是：目标 1。优化在NSCLC操作中术中使用的MSPEN技术。我们将发展下一代 用于开放和机器人NSCLC手术的MSPEN平台； AIM 2。验证MSPEN进行NSCLC诊断。 我们将进行一项前瞻性观察研究，允许胸外科医生验证该技术 OR中的NSCLC诊断； AIM 3。验证MSPEN在NSCLC中进行术中手术边缘评估。 我们将验证MSPEN技术在体内和Ex Vivo中进行手术余量评估，包括最多 目前在临床护理中忽略的代表性组织边缘。我们的建议有可能 为外科医生提供可变革性的好处，以促进肺癌患者的手术护理标准。