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

Adenocarcinoma Clinical Trial

— DONTBIOPCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795184
• Other study ID #: MKT-2008-BE-01
• Status: Completed
• Phase: N/A
• First received: November 20, 2008
• Last updated: May 2, 2016
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: May 2016
• Source: Mauna Kea Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barrett Syndrome
• Barrett's Esophagus
• Barrett's Syndrome
• Syndrome

Intervention

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.
• HDWLE

• pCLE

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Nantes
Germany	Klinikum rechts der Isar	Munich	Bayern
United States	Mayo Clinic	Jacksonville	Florida
United States	Veterans Affairs Hospital	Kansas City	Missouri
United States	New York Presbyterian Hospital/Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Mauna Kea Technologies	Cellvizio Inc., Emissary International LLC

Countries where clinical trial is conducted

United States,  France,  Germany, 

References & Publications (1)

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 confo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No