Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy (DONTBIOPCE)

May 2, 2016 updated by: Mauna Kea Technologies
This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and specificity to a level that would be acceptable to avoid random biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings of standard white light endoscopy (high number of random biopsies, less than ideal directed biopsy of suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity with resultant high false positives, again resulting in many unnecessary biopsies).

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093 Cedex 1
        • Centre Hospitalier Universitaire
  • Germany
    • Bayern
      • Munich, Bayern, Germany
        • Klinikum rechts der Isar
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Hospital
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital/Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with documented or suspected Barrett's esophagus presenting for endoscopy
  2. Age > 18 years
  3. Ability to provide written, informed consent

Exclusion Criteria:

  1. Presence of erosive esophagitis
  2. Inability to obtain biopsies due to anticoagulation, varices, etc.
  3. Allergy to fluorescein, pregnancy
  4. Presence of an esophageal mass other than small 10mm or less nodules
  5. Renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Imaging Procedures HDWLE first NBI second and pCLE
All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Device: Imaging procedures (NBI)

Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order.

Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete.

Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed.

After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.

Device: HDWLE
Device: pCLE
Other Names:
  • Cellvizio
Other: Imaging Procedures NBI first HDWLE second and pCLE
All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Device: Imaging procedures (NBI)

Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order.

Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete.

Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed.

After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.

Device: HDWLE
Device: pCLE
Other Names:
  • Cellvizio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Time Frame: Centralized histopathology confirmation within 4-6 weeks
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Centralized histopathology confirmation within 4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mauna Kea Technologies

Collaborators

Emissary International LLC
Cellvizio Inc.

Investigators

  • Principal Investigator: Prateek Sharma, MD, Veterans Affairs Hospital, Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKT-2008-BE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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