a/LCI-OCT Pilot in Esophagus

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392167
• Other study ID #: Pro00090173_1
• Secondary ID: R01CA210544
• Status: Completed
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: November 29, 2022

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 29, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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