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：在手术去除固体癌症时，组织诊断至关重要，以进行边缘评估和最佳切除。但是，固体恶性肿瘤。切除，冷冻部分分析，可以是主观的，需要特殊病理专业知识，是劳动和耗时，并使患者暴露于麻醉和手术部位感染的风险增加。报道了高度势型手动生物相容性质谱设备的发展， “ Masspec Pen”，用于对离体和体内组织的快速和非破坏性诊断（Zhang等，Science，Science Translational Medicine，2017，9，EAAN3968）。评估来自组织的疾病状态分子预测因素，从组织或损害到组织和几秒钟。技术和压制者的进步是如此，这将是Vecome的偏见，可以向前飞跃在癌症诊断和边缘评估中的术中使用。贝勒医学院，我们建议在背景下进一步开发和验证Masspec笔 OFES在手术边缘评估中的术中使用。 AIM 1。优化Masspec笔用于乳房和胰腺癌。接近实时的分子检测能力，用于癌症诊断以及操作特征对临床的使用有吸引力。并进一步确定和开发开发检测检测能力在各种肿瘤细胞浓度和组织深度处（AIM 1A）。分类器将扩大肿瘤异质性的协会各个方面，及其性能（灵敏度，特异性和准确性）使用独立样品集（AM 1B）进一步验证。 AIM 2。验证Masspec笔以进行术中癌症诊断和手术边缘评估。示范Massspec笔允许体内癌症的诊断和手术边缘评估深刻的临床意义。在漂白剂（AIM 2A）和胰腺（AIM 2B）癌症手术期间将进行体内使用技术贝勒医学学院的预测性诊断和手术边缘状态将与临床结果进行比较对于同一患者，使用标准临床方法评估其临床用途的临床实用性。

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）

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：
10.1101/2023.06.01.543306
发表时间：
2023
期刊：
bioRxiv : the preprint server for biology
影响因子：
0
作者：
Chappel,JessieR;King,MaryE;Fleming,Jonathon;Eberlin,LiviaS;Reif,DavidM;Baker,ErinS
通讯作者：
Baker,ErinS

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

DOI：
10.3390/cancers15102842
发表时间：
2023-05-19
期刊：
CANCERS
影响因子：
5.2
作者：
Krieger, Anna C. C.;Macias, Luis A. A.;Goodman, J. Clay;Brodbelt, Jennifer S. S.;Eberlin, Livia S. S.
通讯作者：
Eberlin, Livia S. S.

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

DOI：
10.1021/acs.analchem.3c02389
发表时间：
2023-08-29
期刊：
ANALYTICAL CHEMISTRY
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.

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

DOI：
10.1016/j.jbc.2023.102902
发表时间：
2023-03
期刊：
JOURNAL OF BIOLOGICAL CHEMISTRY
影响因子：
4.8
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.;Zuniga, Luis;Tomazela, Daniela;Beaumont, Maribel;Han, Jin-Hwan;Eberlin, Livia S.
通讯作者：
Eberlin, Livia S.