NCT04392167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 28, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

May 14, 2020

Results QC Date

October 25, 2023

Last Update Submit

November 27, 2023

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    day 1

Study Arms (1)

a/LCI-OCT Imaging of the Esophagus

EXPERIMENTAL
Device: a/LCI-OCT imaging probeProcedure: esophageal biopsy

Interventions

a/LCI-OCT imaging probeDEVICE

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

a/LCI-OCT Imaging of the Esophagus
esophageal biopsyPROCEDURE

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

a/LCI-OCT Imaging of the Esophagus

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related 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.

    PMID: 20854820BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Dr. Adam Wax
Organization
Duke University
a.wax@duke.edu
919-660-5143

Study Officials

  • Adam Wax, Ph.D.

    Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 18, 2020

Study Start

November 24, 2020

Primary Completion

November 22, 2022

Study Completion

November 29, 2022

Last Updated

November 28, 2023

Results First Posted

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)