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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA210544 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of North Carolina, Chapel Hill | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a/LCI-OCT Imaging of the Esophagus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a/LCI-OCT imaging probe | Device | a/LCI and OCT imaging measurements of several locations in the esophagus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Presenting to University of North Carolina (UNC) for routine care upper endoscopy
Meet one of the following criteria:
Aged 18 to 80
Able to read, comprehend, and understand the informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Wax, Ph.D. | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20854820 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant did not report age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of correct identifications | day 1 | positive biopsies | positive biopsies |
|
1 week
Participants were contacted 1 week after a/LCI-OCT imaging to assess any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sore throat | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Wax | Duke University | 919-660-5143 | a.wax@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2020 | Oct 19, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2022 | Dec 7, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| esophageal biopsy | Procedure | biopsies of esophageal tissue imaged by a/LCI-OCT probe |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One participant did not report sex. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Stage of Barrett's Esophagus | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| positive biopsies |
|
|
| 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. | Posted | Number | percentage of correct identifications | day 1 | negative biopsies | negative biopsies |
|
|
|
| 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 | Posted | Number | percentage of participants | day 1 |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 22 |
| 37 |
| throat tightness / trouble swallowing | Surgical and medical procedures | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |