Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| a/LCI-OCT imaging probe | Device | — | UNRESOLVED |
| esophageal biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- a/LCI-OCT Imaging of the Esophagus
- interventionNames
- Device: a/LCI-OCT imaging probe
- Procedure: esophageal biopsy
Primary outcomes (2)
- measure
- Percentage of Correctly Identified Positive (Dysplastic) Biopsies
- timeFrame
- day 1
- description
- 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.
- measure
- Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies
- timeFrame
- day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDTerry 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 20854820