Staging of Superficial EAC Using VLE

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

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

Study Overview

• Status: Terminated
• Conditions: Esophageal Cancer
• Intervention / Treatment: Diagnostic test: VLE imaging for staging EAC

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: VLE imaging for staging EAC; Volumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC); 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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Cadman L Leggett, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): September 8, 2021

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17-002723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes