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

This study has been completed.
Sponsor:
Collaborators:
Cellvizio Inc.
Emissary International LLC
Information provided by (Responsible Party):
Mauna Kea Technologies
ClinicalTrials.gov Identifier:
NCT00795184
First received: November 20, 2008
Last updated: May 2, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Barrett Syndrome
Barrett's Syndrome
Barrett's Esophagus
Barrett Esophagus
Adenocarcinoma
Device: Imaging procedures (NBI)
Device: HDWLE
Device: pCLE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

Resource links provided by NLM:


Further study details as provided by Mauna Kea Technologies:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 122
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cellvizio
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 Name: Cellvizio

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795184

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Missouri
Veterans Affairs Hospital
Kansas City, Missouri, United States, 64128
United States, New York
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
France
Centre Hospitalier Universitaire
Nantes, France, 44093 Cedex 1
Germany
Klinikum rechts der Isar
Munich, Bayern, Germany
Sponsors and Collaborators
Mauna Kea Technologies
Cellvizio Inc.
Emissary International LLC
Investigators
Principal Investigator: Prateek Sharma, MD Veterans Affairs Hospital, Kansas City
  More Information

Publications:
Responsible Party: Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT00795184     History of Changes
Other Study ID Numbers: MKT-2008-BE-01 
Study First Received: November 20, 2008
Results First Received: June 4, 2012
Last Updated: May 2, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mauna Kea Technologies:
Barrett's Esophagus
EsoGastroDuodenoscopy
Barrett's Carcinoma
adenocarcinoma
Cellvizio
endomicroscopy
random biopsy

Additional relevant MeSH terms:
Adenocarcinoma
Barrett Esophagus
Syndrome
Carcinoma
Digestive System Abnormalities
Digestive System Diseases
Disease
Esophageal Diseases
Gastrointestinal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Pathologic Processes

ClinicalTrials.gov processed this record on May 26, 2016