a/LCI-OCT Pilot in Esophagus

Duke University

Status: Completed

Conditions: Barrett Esophagus

Treatments: Device: a/LCI-OCT imaging probe; Procedure: esophageal biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04392167

R01CA210544 (U.S. NIH Grant/Contract)

Pro00090173_1

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

a/LCI-OCT Imaging of the Esophagus

Experimental group

Treatment:

Procedure: esophageal biopsy

Device: a/LCI-OCT imaging probe