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Staging of Superficial EAC Using VLE

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03385343
Collaborator
(none)
49
Enrollment
1
Location
1
Arm
52.1
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: VLE imaging for staging EAC
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)
Actual Study Start Date :
May 5, 2017
Actual Primary Completion Date :
Sep 8, 2021
Actual Study Completion Date :
Sep 8, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subjects whose VLE results correlates with the histology results for T1 EAC depth of invasion [1 year]

      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.

    2. Percentage of subjects whose VLE results correlates with the histology results for staging T1 EAC [1 year]

      To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cadman Leggett, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03385343
    Other Study ID Numbers:
    • 17-002723
    First Posted:
    Dec 28, 2017
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Sep 20, 2021