Barrett Esophagus
Conditions
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.
Interventions
DEVICEa/LCI-OCT imaging probe
a/LCI and OCT imaging measurements of several locations in the esophagus
PROCEDUREesophageal biopsy
biopsies of esophageal tissue imaged by a/LCI-OCT probe
Sponsors
National Cancer Institute (NCI)
University of North Carolina, Chapel Hill
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Correctly Identified Positive (Dysplastic) Biopsies | 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. |
| Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image | day 1 | percentage of participants that had adequate tissue contact to acquire high quality a/LCI-OCT images |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| a/LCI-OCT Imaging of the Esophagus All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | unable to swallow a/LCI-OCT probe | 6 |
Baseline characteristics
| Characteristic | a/LCI-OCT Imaging of the Esophagus |
|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 37 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 28 Participants |
| Stage of Barrett's Esophagus Barrett's Esophagus with high grade dysplasia | 16 Participants |
| Stage of Barrett's Esophagus Barrett's Esophagus with low grade dysplasia | 7 Participants |
| Stage of Barrett's Esophagus history of Barrett's Esophagus with CEIM (complete eradication of intestinal metaplasia) | 1 Participants |
| Stage of Barrett's Esophagus non-dysplastic Barrett's Esophagus | 12 Participants |
| Stage of Barrett's Esophagus normal asymptomatic control without history of Barrett's Esophagus | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 22 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
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.
Time frame: day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| a/LCI-OCT Imaging of the Esophagus | Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies | 93.0 percentage of correct identifications |
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.
Time frame: day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| a/LCI-OCT Imaging of the Esophagus | Percentage of Correctly Identified Positive (Dysplastic) Biopsies | 100.0 percentage of correct identifications |
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
Time frame: day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| a/LCI-OCT Imaging of the Esophagus | Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image | 83.8 percentage of participants |