Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion
研究概览
简要总结
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
详细描述
Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. VLE has been used to detect dysplasia associated with Barrett's esophagus (BE) but its use in cancer staging has not been previously explored. The investigators propose that VLE can accurately and comprehensively stage T1 EAC.
VLE scans will be analyzed using an automated computer algorithm to measure degree of signal attenuation over areas demarcated for endoscopic mucosal resection (EMR). The signal attenuation cut-off established will be used to classify cancers as superficial versus deep. EMR specimens will be reviewed histopathologically for grade of tumor differentiation, depth of invasion, and presence or absence of lymphovascular invasion. Depth of tumor invasion will be measured and used to classify cancers as superficial versus deep.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over the age of 18
- •Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus.
- •Ability to provide written, informed consent
- •No significant esophagitis (LA grade <B, C, and D)
排除标准
- •Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
- •Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD)
- •Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- •Prior esophageal or gastric surgical resection
- •Significant esophageal stricture requiring dilatation
- •Patients who require anticoagulation for who biopsy would be contraindicated
- •Patients who are known to be pregnant
结局指标
主要结局
Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion
时间窗: 1 day
A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology.
Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC
时间窗: 1 day
To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard.
次要结局
未报告次要终点
研究者
Cadman Leggett
Principal Investigator
Mayo Clinic