Advanced Development of the MasSpec Pen for Cancer Diagnosis and Surgical Margin Evaluation

用于癌症诊断和手术边缘评估的 MasSpec Pen 的先进开发

基本信息

批准号：
10462343
负责人：
Livia Schiavinato Eberlin
金额：
$ 48.54万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-05 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10462343
关键词：
Ablation Advanced Development Anesthesia procedures Animals Biochemical Breast Cancer Detection Cancer Patient Cellularity Clinical Collaborations Consumption Decision Making Detection Development Devices Diagnosis Disease Emerging Technologies Evaluation Excision Freezing Frozen Sections Health Care Costs Histology Human In Situ Incidence Injections Label Lasers Malignant Neoplasms Malignant neoplasm of pancreas Mass Spectrum Analysis Measures Medical Device Medicine Methods Modality Molecular Molecular Diagnosis Molecular Profiling Morphologic artifacts Nature Operative Surgical Procedures Pancreas Pathologist Pathology Patient Care Patients Performance Preparation Procedures Prognosis Reporting Reproducibility Risk Sampling Sensitivity and Specificity Site Software Tools Solid Specificity Speed Surgeon Surgical Oncology Surgical Wound Infection Surgical margins Techniques Technology Testing Time Tissue Sample Tissues Translational Research Treatment outcome Validation Visualization Water biomaterial compatibility cancer diagnosis cancer surgery clinical decision-making college design diagnosis evaluation fluorescence-guided surgery improved in vivo innovation ionization malignant breast neoplasm medical specialties neoplastic cell operation precision medicine programs specific biomarkers standard of care tool translational medicine treatment strategy tumor tumor heterogeneity

项目摘要

ABSTRACT: Tissue diagnosis is critical during surgical removal of solid cancers for margin evaluation and optimal excision. Complete resection of the tumor is associated with an improved prognosis for almost all types of solid malignancies. However, the standard clinical approach for intraoperative assessment of extent of tumor excision, frozen section analysis, can be subjective, require on site specialty pathology expertise, is labor- and time- consuming, and exposes patients to increased risks of anesthesia and surgical site infection. Our team has reported the development of a highly innovative handheld and biocompatible mass spectrometry device, the “MasSpec Pen”, for rapid and non-destructive diagnosis of ex vivo and in vivo tissues (Zhang et al, Science Translational Medicine, 2017, 9, eaan3968). The MasSpec Pen provides the unique and transformative ability to assess molecular predictors of disease state directly from tissue samples without causing harm or damage to the tissues and in seconds. We believe the MasSpec Pen offers substantial improvements over existing technologies and represents an advance that is so innovative that will become a disruptive leap forward for intraoperative use in cancer diagnosis and margin evaluation. In collaboration with surgeons and pathologists at the Baylor College of Medicine, we propose to further develop and validate the MasSpec Pen within the context of its intended intraoperative use in surgical margin evaluation. The objectives of this proposal include: Aim 1. Optimize the MasSpec Pen for breast and pancreatic cancer detection. The MasSpec Pen provides near real time molecular detection capabilities for cancer diagnosis along with operational features that are attractive for clinical use. Technical refinements will be pursued to improve performance for intraoperative use, and to further determine and develop detection capabilities at various tumor cell concentration and tissue depths (Aim 1a). Performance measures (e.g. sensitivity and reproducibility) will be systematically evaluated. Statistical classifiers will be expanded considering aspects of tumor heterogeneity, refined, and their performance (sensitivity, specificity and accuracy) further validated using independent sample sets (Aim 1b). Aim 2. Validate the MasSpec Pen for intraoperative cancer diagnosis and surgical margin evaluation. The demonstration that the MasSpec Pen allows in vivo cancer diagnosis and surgical margin evaluation has profound clinical implications. Technical validation of cancer detection capabilities and final tuning of the technology for in vivo use will be pursued during breast (Aim 2a) and pancreatic (Aim 2b) cancer surgeries at Baylor College of Medicine. Predictive diagnosis and surgical margin status will be compared to clinical results for the same patients using standard clinical approaches to evaluate its clinical usefulness for clinical use.

摘要：在实体癌手术切除过程中，组织诊断对于切缘评估和诊断至关重要。最佳切除肿瘤与几乎所有类型的预后改善相关。然而，术中评估肿瘤范围的标准临床方法。切除、冰冻切片分析，可能是主观的，需要现场专业病理学专业知识，是人工和耗时，并且使患者面临麻醉和手术部位感染的风险增加。报道了一种高度创新的手持式和生物相容性质谱设备的开发， “MasSpec Pen”，用于快速、无损地诊断离体和体内组织（Zhang 等人，Science 转化医学，2017，9，eaan3968）MasSpec Pen 提供了独特的变革能力。直接从组织样本评估疾病状态的分子预测因子，而不会对身体造成伤害或损害我们相信 MasSpec Pen 比现有的产品有了显着的改进。技术，代表了一种创新性的进步，将成为颠覆性的飞跃与外科医生和病理学家合作，在癌症诊断和边缘评估中使用。贝勒医学院，我们建议在该背景下进一步开发和验证 MasSpec Pen 该提案的目标包括：目标 1. 优化 MasSpec Pen 用于乳腺癌和胰腺癌检测。用于癌症诊断的近实时分子检测功能以及将追求技术改进以提高术中使用的性能，并进一步确定和开发不同肿瘤细胞浓度和组织深度的检测能力（目标 1a）将系统地评估性能指标（例如灵敏度和再现性）。考虑到肿瘤异质性、细化及其性能，分类器将得到扩展（敏感性、特异性和准确性）使用独立样本集进一步验证（目标 1b）。目标 2. 验证 MasSpec Pen 用于术中癌症诊断和手术切缘评估。 MasSpec Pen 可以进行体内癌症诊断和手术切缘评估的演示癌症检测能力的技术验证和最终调整。将在乳腺癌（目标 2a）和胰腺癌（目标 2b）手术中寻求体内使用技术贝勒医学院将预测诊断和手术切缘状态与临床结果进行比较。对于相同的患者使用标准临床方法来评估其临床用途。

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Aggregated Molecular Phenotype Scores: Enhancing Assessment and Visualization of Mass Spectrometry Imaging Data for Tissue-Based Diagnostics.

聚合分子表型评分：增强基于组织的诊断的质谱成像数据的评估和可视化。

DOI：
发表时间：
2023-08-29
期刊：
影响因子：
7.4
作者：
Chappel, Jessie R;King, Mary E;Fleming, Jonathon;Eberlin, Livia S;Reif, David M;Baker, Erin S
通讯作者：
Baker, Erin S

Mass Spectrometry Imaging Reveals Abnormalities in Cardiolipin Composition and Distribution in Astrocytoma Tumor Tissues.

质谱成像揭示星形细胞瘤肿瘤组织中心磷脂组成和分布的异常。

DOI：
发表时间：
2023-05-19
期刊：
影响因子：
5.2
作者：
Krieger, Anna C;Macias, Luis A;Goodman, J Clay;Brodbelt, Jennifer S;Eberlin, Livia S
通讯作者：
Eberlin, Livia S

Long-chain polyunsaturated lipids associated with responsiveness to anti-PD-1 therapy are colocalized with immune infiltrates in the tumor microenvironment.

与抗 PD-1 治疗反应相关的长链多不饱和脂质与肿瘤微环境中的免疫浸润共定位。

DOI：
发表时间：
2023-03
期刊：
影响因子：
0
作者：
King, Mary E;Yuan, Robert;Chen, Jeremy;Pradhan, Komal;Sariol, Isabel;Li, Shirley;Chakraborty, Ashish;Ekpenyong, Oscar;Yearley, Jennifer H;Wong, Janica C;Zúñiga, Luis;Tomazela, Daniela;Beaumont, Maribel;Han, Jin;Eberlin, Livia S
通讯作者：
Eberlin, Livia S

Utilizing Aggregated Molecular Phenotype (AMP) Scores to Visualize Simultaneous Molecular Changes in Mass Spectrometry Imaging Data.

利用聚合分子表型 (AMP) 评分可视化质谱成像数据中的同时分子变化。

DOI：
发表时间：
2023-06-05
期刊：
影响因子：
0
作者：
Chappel, Jessie R;King, Mary E;Fleming, Jonathon;Eberlin, Livia S;Reif, David M;Baker, Erin S
通讯作者：
Baker, Erin S

Rapid diagnosis and tumor margin assessment during pancreatic cancer surgery with the MasSpec Pen technology.

使用 MasSpec Pen 技术在胰腺癌手术期间进行快速诊断和肿瘤边缘评估。

DOI：
发表时间：
2021
期刊：
影响因子：
11.1
作者：
King, Mary E;Zhang, Jialing;Lin, John Q;Garza, Kyana Y;DeHoog, Rachel J;Feider, Clara L;Bensussan, Alena;Sans, Marta;Krieger, Anna;Badal, Sunil;Keating, Michael F;Woody, Spencer;Dhingra, Sadhna;Yu, Wendong;Pirko, Christopher;Brahmbhatt, Kir
通讯作者：
Brahmbhatt, Kir