文章：

用于即时膀胱肿瘤诊断的拉曼光谱系统：依据欧洲医疗器械法规（MDR2017/745）的系统开发与体内原理验证研究

Raman Spectroscopy for Instant Bladder Tumor Diagnosis: System Development and In Vivo Proof-Of-Principle Study in Accordance with the European Medical Device Regulation (MDR2017/745)

原文发布日期：23 September 2024

DOI: 10.3390/cancers16183238

类型: Article

开放获取: 是

英文摘要：

This work reports on an in vivo Raman-based endoscopy system, invaScope, enabling Raman measurements of healthy and tumor bladder tissue during an endoscopic procedure in the operating theatre. The presented study outlines the progression from the initial concept (validated through previously performed ex vivo studies) to the approval and implementation of a clinical investigational device according to the requirement within the framework of the European Medical Device Regulation (MDR2017/745). The study’s primary objective was to employ the invaScope Raman system within the bladder, capturing in vivo spectroscopic Raman data followed by standard histo- and cytopathological examinations of urological tissue (considered the gold standard). The collected data were analyzed and correlated with histopathological findings post-procedure. Additionally, the study aimed to assess the feasibility of using diagnostic equipment, probes, and software for application in a clinical setting, evaluating usability aspects that are important during surgical procedures. This research represents a pivotal step toward advancing Raman spectroscopy for routine clinical use in characterizing bladder lesions.

摘要翻译： 

本研究报道了一种基于拉曼光谱的体内内窥镜系统——invaScope，该系统能够在手术室的内窥镜操作过程中对健康与肿瘤膀胱组织进行拉曼测量。研究阐述了从初始概念（通过前期离体实验验证）到依据欧洲医疗器械法规（MDR2017/745）框架要求，完成临床研究设备的审批与实施的全过程。本研究的主要目标是在膀胱内应用invaScope拉曼系统，采集体内拉曼光谱数据，并同步对泌尿组织进行标准的组织病理学与细胞病理学检测（作为金标准）。采集的数据在术后与组织病理学结果进行关联分析。此外，本研究旨在评估诊断设备、探头及软件在临床环境中应用的可行性，重点考察其在手术过程中的可用性。该研究标志着拉曼光谱技术向临床常规应用于膀胱病变表征迈出了关键一步。

原文链接：

Raman Spectroscopy for Instant Bladder Tumor Diagnosis: System Development and In Vivo Proof-Of-Principle Study in Accordance with the European Medical Device Regulation (MDR2017/745)