a/LCI-OCT Pilot in Esophagus

Not Applicable

Completed

• Conditions: Barrett Esophagus
• Interventions: Device: a/LCI-OCT imaging probe; Procedure: esophageal biopsy

• Registration Number: NCT04392167
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-18
• Study Start: 2020-11-24
• Primary Completion: 2022-11-22
• Study Completion: 2022-11-29
• Results First Submitted: 2023-10-25
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Results First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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Exclusion Criteria

• Prior esophageal surgery (uncomplicated nissen fundoplication OK)
• Pregnant women
• Unable to provide written informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
a/LCI-OCT Imaging of the Esophagus	a/LCI-OCT imaging probe	-
a/LCI-OCT Imaging of the Esophagus	esophageal biopsy	-

Primary Outcome Measures

Name	Time	Method
Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies	day 1	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.
Percentage of Correctly Identified Positive (Dysplastic) Biopsies	day 1	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image	day 1	percentage of participants that had adequate tissue contact to acquire high quality a/LCI-OCT images

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States