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

Mauna Kea Technologies

Status: Completed

Conditions: Barrett Syndrome; Barrett Esophagus; Adenocarcinoma; Barrett's Syndrome; Barrett's Esophagus

Treatments: Device: Imaging procedures (NBI); Device: pCLE; Device: HDWLE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00795184

MKT-2008-BE-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Imaging Procedures HDWLE first NBI second and pCLE

Other group

Description:

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.

Treatment:

Device: Imaging procedures (NBI)

Device: pCLE

Device: HDWLE

Imaging Procedures NBI first HDWLE second and pCLE

Other group

Description:

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.

Treatment:

Device: Imaging procedures (NBI)

Device: pCLE

Device: HDWLE