Staging of Superficial EAC Using VLE

Mayo Clinic30 enrolled

Overview

This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Esophageal Cancer

Interventions

VLE imaging for staging EACDIAGNOSTIC_TEST

Volumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 day

Data from ClinicalTrials.gov

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