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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795184
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : May 3, 2016
Last Update Posted : May 3, 2016
Sponsor:
Collaborators:
Cellvizio Inc.
Emissary International LLC
Information provided by (Responsible Party):
Mauna Kea Technologies

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE November 21, 2008
Results First Submitted Date  ICMJE June 4, 2012
Results First Posted Date  ICMJE May 3, 2016
Last Update Posted Date May 3, 2016
Study Start Date  ICMJE November 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
Comparative histopathology-confirmed measures of per lesion sensitivity and per lesion specificity of pCLE for the detection of high grade dysplasia and early carcinoma in Barrett's esophagus. [ Time Frame: Centralized histopathology confirmation within 4-6 weeks ]
Change History Complete list of historical versions of study NCT00795184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
Official Title  ICMJE Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Barrett Syndrome
  • Barrett's Syndrome
  • Barrett's Esophagus
  • Barrett Esophagus
  • Adenocarcinoma
Intervention  ICMJE
  • 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 Name: Cellvizio
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Imaging procedures (NBI)
    • Device: HDWLE
    • Device: pCLE
  • 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.
    Interventions:
    • Device: Imaging procedures (NBI)
    • Device: HDWLE
    • Device: pCLE
Publications * Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2016)
122
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2008)
85
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00795184
Other Study ID Numbers  ICMJE MKT-2008-BE-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mauna Kea Technologies
Study Sponsor  ICMJE Mauna Kea Technologies
Collaborators  ICMJE
  • Cellvizio Inc.
  • Emissary International LLC
Investigators  ICMJE
Principal Investigator: Prateek Sharma, MD Veterans Affairs Hospital, Kansas City
PRS Account Mauna Kea Technologies
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP