a/LCI-OCT Pilot in Esophagus

Duke University37 enrolled

Overview

This study will test a newly developed dual modality probe, including optical coherence tomography (OCT) and angle-resolved low-coherence interferometry (a/LCI), in the human esophagus to determine 1) whether adequate tissue contact can be attained by the probe to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium. This pilot study will test the operating characteristics of the probe and collect data for further optimization of the a/LCI-OCT device.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Barrett Esophagus

Interventions

a/LCI-OCT imaging probeDEVICE

a/LCI and OCT imaging measurements of several locations in the esophagus

esophageal biopsyPROCEDURE

biopsies of esophageal tissue imaged by a/LCI-OCT probe

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Presenting to University of North Carolina (UNC) for routine care upper endoscopy * Meet one of the following criteria: 1. Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR, 2. History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR, 3. Normal asymptomatic controls without any history of dysplastic Barrett's Esophagus * Aged 18 to 80 * Able to read, comprehend, and understand the informed consent document Exclusion Criteria: * Prior esophageal surgery (uncomplicated nissen fundoplication OK) * Pregnant women * Unable to provide written informed consent

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Percentage of Correctly Identified Positive (Dysplastic) Biopsies

Sensitivity of the a/LCI-OCT probe to detect dysplasia as measured by percentage of correctly identified positive biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.

Time frame: day 1

Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies

Specificity of the a/LCI-OCT probe to detect absence of dysplasia as measured by percentage of correctly identified negative biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.

Time frame: day 1

Secondary Outcomes

Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image

percentage of participants that had adequate tissue contact to acquire high quality a/LCI-OCT images

Time frame: day 1

Data from ClinicalTrials.gov

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