Staging of Superficial EAC Using VLE

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2021-09-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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VLE imaging of stage 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.

Group Type EXPERIMENTAL

VLE imaging for staging EAC

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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VLE imaging for staging EAC

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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NvisionVLE Imaging System

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No