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This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. VLE has been used to detect dysplasia associated with Barrett's esophagus (BE) but its use in cancer staging has not been previously explored. The investigators propose that VLE can accurately and comprehensively stage T1 EAC.
VLE scans will be analyzed using an automated computer algorithm to measure degree of signal attenuation over areas demarcated for endoscopic mucosal resection (EMR). The signal attenuation cut-off established will be used to classify cancers as superficial versus deep. EMR specimens will be reviewed histopathologically for grade of tumor differentiation, depth of invasion, and presence or absence of lymphovascular invasion. Depth of tumor invasion will be measured and used to classify cancers as superficial versus deep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLE imaging of stage EAC | Experimental | All subjects will receive VLE imaging for staging EAC. Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLE imaging for staging EAC | Diagnostic Test | Volumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion | A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology. | 1 day |
| Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC | To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard. | 1 day |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cadman L Leggett, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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Patients undergoing clinical care through our institution's Barrett's esophagus unit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Volumetric Laser Endomicroscopy | Patients with Barrett's esophagus and early esophageal adenocarcioma (T1) who were undergoing a clinically indicated endoscopic mucosal resection (EMR) were invited to participate in the study. EMR specimens were imaged (ex-vivo) using volumetric laser endomicroscopy (VLE). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Volumetric Laser Endomicroscopy | Patients with Barrett's esophagus and early esophageal adenocarcioma (T1) who were undergoing a clinically indicated endoscopic mucosal resection (EMR) were invited to participate in the study. EMR specimens were imaged (ex-vivo) using volumetric laser endomicroscopy (VLE). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion | A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology. | Data was not collected | Posted | 1 day |
|
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Adverse Events were not monitored/assessed due to ex-vivo nature of the study
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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 | VLE in Staging T1 EAC | The diagnostic performance of VLE in staging T1 EAC | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Buller Clinical Research Coordinator | Mayo Clinic | 507-255-4803 | Buller.Kevin@mayo.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 | Mar 12, 2021 | Feb 22, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2021 | Dec 9, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC | To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard. | Data was not collected | Posted | 1 day |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |