Barrett Esophagus
Conditions
Brief summary
This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained 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.
Interventions
DEVICEoptical coherence tomography
OCT measurements of 5 locations in the esophagus
Sponsors
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
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
No
Inclusion criteria
1. Presenting to University of North Carolina (UNC) for routine care upper endoscopy 2. Meet one of the following criteria: 1. Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR, 2. History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+ 3. Aged 18 to 80 4. Able to read, comprehend, and understand the informed consent document.
Exclusion criteria
1. Prior esophageal surgery (uncomplicated nissen fundoplication OK) 2. Pregnant women 3. Unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa | at baseline | Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy. |
| Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa | at baseline | Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image | at baseline | Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OCT of Esophagus All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | unable to swallow OCT probe | 16 |
Baseline characteristics
| Characteristic | OCT of Esophagus |
|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Region of Enrollment United States | 53 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 48 Participants |
| Stage of Barrett's Esophagus Barrett's Esophagus with high grade dysplasia | 21 Participants |
| Stage of Barrett's Esophagus Barrett's Esophagus with low grade dysplasia | 24 Participants |
| Stage of Barrett's Esophagus non-dysplastic Barrett's Esophagus | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 8 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
Time frame: at baseline
Population: Participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCT of Esophagus | Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa | 84.6 percentage of imaged sites |
Primary
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
Time frame: at baseline
Population: Participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCT of Esophagus | Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa | 93.1 percentage of imaged sites |
Secondary
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image
Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.
Time frame: at baseline
Population: Participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCT of Esophagus | Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image | 80.5 percentage of imaged sites |