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


N/A
18 Years
N/A
Not Enrolling
Both
Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus, Adenocarcinoma

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Trial Information

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


This is a cross-over tandem study 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 NBI (low specificity with
resultant high false positives, again resulting in many unnecessary biopsies).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

Centralized histopathology confirmation within 4-6 weeks

Safety Issue:

Yes

Principal Investigator

Prateek Sharma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Veterans Affairs Hospital, Kansas City

Authority:

United States: Institutional Review Board

Study ID:

MKT-2008-BE-01

NCT ID:

NCT00795184

Start Date:

November 2008

Completion Date:

February 2010

Related Keywords:

  • Barrett Syndrome
  • Barrett's Syndrome
  • Barrett's Esophagus
  • Barrett Esophagus
  • Adenocarcinoma
  • Barrett's Esophagus
  • EsoGastroDuodenoscopy
  • Barrett's Carcinoma
  • adenocarcinoma
  • Cellvizio
  • endomicroscopy
  • random biopsy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus

Name

Location

Mayo ClinicJacksonville, Florida  32224
New York Presbyterian Hospital/Columbia University Medical CenterNew York, New York  10032
Veterans Affairs HospitalKansas City, Missouri  64128