Staging of Superficial EAC Using VLE

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
VLE imaging of stage EAC	VLE imaging for staging EAC	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion	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	1 day	To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard.

Secondary Outcome Measures