a/LCI-OCT Pilot in Esophagus

Study Overview
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Brief Summary
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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.

Official Title
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Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An a/LCI-Optical Coherence Tomography (OCT) Pilot Study

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Device: a/LCI-OCT imaging probe
* Procedure: esophageal biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting to University of North Carolina (UNC) for routine care upper endoscopy Meet one of the following criteria: Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR, History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a/LCI-OCT Imaging of the Esophagus<br> | Device: a/LCI-OCT imaging probe<br>* a/LCI and OCT imaging measurements of several locations in the esophagus<br>Procedure: esophageal biopsy<br>* biopsies of esophageal tissue imaged by a/LCI-OCT probe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | day 1 |