A Prospective Pre-Market Proof-of-Concept Study for Ex Vivo Raman Spectroscopy Measurements on Excised Lung Tissue With the Sentry System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- investigate the variability of the Raman spectra using data points ex vivo on recently excised lung tissue, with at least one third of spectra labeled as normal and cancerous based on subsequent histopathology assessment.
研究概览
简要总结
In this proof-of-concept, ex vivo study, the study team will investigate whether Raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue.
详细描述
Lung cancer is the most prevalent form of cancer worldwide and the leading cause of cancer-related deaths. Despite recent advances in treatment, the five-year survival rate remains below 25% [State of Lung Cancer Report 2021,American Lung Association. This is largely due to the fact that most patients are diagnosed only at advanced stages of the disease when treatments are ineffective and the prognosis is poor. The National Lung Screening Trial demonstrated the utility of lung cancer screening by low-dose computed tomography (CT) to improve early detection\ and reduce lung cancer-related mortality by 20%. Earlier detection of lung lesions in turn created an increased need for better early diagnosis modalities.
Reveal Surgical is developing medical devices for tissue characterization based on Raman spectroscopy technology.
In this proof-of-concept, ex vivo study, the study team will investigate whether Raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above,
- •With suspected or confirmed diagnosis of lung cancer,
- •Scheduled for lobectomy surgery,
- •Able to give informed consent.
排除标准
- •Suspected or confirmed diagnosis of mucinous adenocarcinoma of the lung
- •Undergoing neoadjuvant therapy. (This exclusion criterion is intended to minimize confounding optical signals such as fluorescence or near-infrared Raman signals that could arise from the presence of chromophores derived from neoadjuvant medication.)
- •Previously diagnosed with cystic fibrosis or other lung disease, with the exception of Chronic Obstructive Pulmonary Disease (COPD) and ILD (Interstitial Lung Disease), i.e., patients with COPD or ILD will not be excluded from the study.
- •Tumor size below 1cm3
- •Resected lobe does not allow Surgical Pathology team to section two study specimens of minimal size 1.5cm × 1.5cm. In this case the patient will be found ineligible after consent.
结局指标
主要结局
investigate the variability of the Raman spectra using data points ex vivo on recently excised lung tissue, with at least one third of spectra labeled as normal and cancerous based on subsequent histopathology assessment.
时间窗: 1 year
whether ex vivo cancerous and normal human lung tissue yield distinct Raman signatures.
次要结局
未报告次要终点