手持式手术用生物兼容质谱探头的临床转化与评估。

Clinical Translation and Evaluation of a Handheld and Biocompatible Mass Spectrometry Probe for Surgical Use.

机构信息

Department of Chemistry, The University of Texas at Austin, Austin, TX.

Department of Biomedical Engineering, The University of Texas at Austin, Austin, TX.

出版信息

Clin Chem. 2021 Sep 1;67(9):1271-1280. doi: 10.1093/clinchem/hvab098.

DOI:10.1093/clinchem/hvab098

PMID:34263289

Abstract

BACKGROUND

Intraoperative tissue analysis and identification are critical to guide surgical procedures and improve patient outcomes. Here, we describe the clinical translation and evaluation of the MasSpec Pen technology for molecular analysis of in vivo and freshly excised tissues in the operating room (OR).

METHODS

An Orbitrap mass spectrometer equipped with a MasSpec Pen interface was installed in an OR. A "dual-path" MasSpec Pen interface was designed and programmed for the clinical studies with 2 parallel systems that facilitated the operation of the MasSpec Pen. The MasSpec Pen devices were autoclaved before each surgical procedure and were used by surgeons and surgical staff during 100 surgeries over a 12-month period.

RESULTS

Detection of mass spectral profiles from 715 in vivo and ex vivo analyses performed on thyroid, parathyroid, lymph node, breast, pancreatic, and bile duct tissues during parathyroidectomies, thyroidectomies, breast, and pancreatic neoplasia surgeries was achieved. The MasSpec Pen enabled gentle extraction and sensitive detection of various molecular species including small metabolites and lipids using a droplet of sterile water without causing apparent tissue damage. Notably, effective molecular analysis was achieved while no limitations to sequential histologic tissue analysis were identified and no device-related complications were reported for any of the patients.

CONCLUSIONS

This study shows that the MasSpec Pen system can be successfully incorporated into the OR, allowing direct detection of rich molecular profiles from tissues with a seconds-long turnaround time that could be used to inform surgical and clinical decisions without disrupting tissue analysis workflows.

摘要

背景

术中组织分析和鉴定对于指导手术过程和改善患者预后至关重要。在这里，我们描述了 MasSpec Pen 技术在手术室（OR）中对体内和新鲜切除组织进行分子分析的临床转化和评估。

方法

在 OR 中安装了配备 MasSpec Pen 接口的轨道阱质谱仪。设计并编程了一种“双路”MasSpec Pen 接口，用于临床研究，有 2 个平行系统，便于 MasSpec Pen 的操作。MasSpec Pen 设备在每次手术前进行高压灭菌，并在 12 个月期间由外科医生和手术人员在 100 次手术中使用。

结果

在甲状旁腺切除术、甲状腺切除术、乳腺和胰腺肿瘤手术中，对甲状腺、甲状旁腺、淋巴结、乳腺、胰腺和胆管组织进行了 715 次体内和离体分析，成功检测到了质谱谱图。MasSpec Pen 能够使用无菌水的液滴轻柔地提取和灵敏地检测各种分子种类，包括小代谢物和脂质，而不会造成明显的组织损伤。值得注意的是，在不影响连续组织学分析工作流程的情况下，实现了有效的分子分析，而且没有报告任何与患者相关的设备相关并发症。