Esophageal Cancer Clinical Trial

Staging of Superficial EAC Using VLE

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

30

Study ID:

NCT03385343

Recruitment Status:

Terminated

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

30

Study ID:

NCT03385343

Recruitment Status:

Terminated

Sponsor:


Mayo Clinic

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