a/LCI-OCT Pilot in Esophagus

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

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 Overview

• Status: Completed
• Conditions: Barrett Esophagus
• Intervention / Treatment: Device: a/LCI-OCT imaging probe; Procedure: esophageal biopsy

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI); University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Adam Wax, Ph.D., PROFESSOR

Publications and helpful links

General Publications

• Terry NG, Zhu Y, Rinehart MT, Brown WJ, Gebhart SC, Bright S, Carretta E, Ziefle CG, Panjehpour M, Galanko J, Madanick RD, Dellon ES, Trembath D, Bennett A, Goldblum JR, Overholt BF, Woosley JT, Shaheen NJ, Wax A. Detection of dysplasia in Barrett's esophagus with in vivo depth-resolved nuclear morphology measurements. Gastroenterology. 2011 Jan;140(1):42-50. doi: 10.1053/j.gastro.2010.09.008. Epub 2010 Sep 18.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: Pro00090173_1; R01CA210544 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No