Esophageal Cancer
Conditions
Brief summary
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTVLE imaging for staging EAC
Volumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC)
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Patient over the age of 18 * Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus. * Ability to provide written, informed consent * No significant esophagitis (LA grade \<B, C, and D)
Exclusion criteria
* Patients who have achieved complete remission of intestinal metaplasia (CR-IM) * Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD) * Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use. * Prior esophageal or gastric surgical resection * Significant esophageal stricture requiring dilatation * Patients who require anticoagulation for who biopsy would be contraindicated * Patients who are known to be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion | 1 day | 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. |
| Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC | 1 day | To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard. |
Countries
United States
Participant flow
Recruitment details
Patients undergoing clinical care through our institution's Barrett's esophagus unit.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Volumetric Laser Endomicroscopy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 68.33 years |
| 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 | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 1 day
Population: Data was not collected
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.
Time frame: 1 day
Population: Data was not collected