Staging of Superficial EAC Using VLE

Study Overview
=================
Brief Summary
-----------------
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.

Detailed Description
-----------------
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.

Official Title
-----------------
Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: VLE imaging for staging EAC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VLE imaging of stage EAC<br>All subjects will receive VLE imaging for staging EAC. Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. | Diagnostic Test: VLE imaging for staging EAC<br>* Volumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC)<br>* Other names: NvisionVLE Imaging System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion | 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. | 1 day | 
| Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC | To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard. | 1 day |