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OpenTrials
Completed

NCT Number: NCT04392167

a/LCI-OCT Pilot in Esophagus

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a/LCI-OCT imaging probe

Device

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

esophageal biopsy

Procedure

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

Primary outcomes

  1. Percentage of Correctly Identified Positive (Dysplastic) Biopsies

    Time frame: 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.

  2. Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies

    Time frame: 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.

Secondary outcomes

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

    Time frame: day 1

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 18, 2020
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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