Staging of Superficial EAC Using VLE
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 11/8/2018 |
| Start Date: | May 5, 2017 |
| End Date: | December 31, 2019 |
Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)
This study is being done to see if the NvisionVLE Imaging System can accurately determine the
diagnostic performance of staging of T1 esophageal adenocarcinoma.
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.
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.
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
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
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