Staging of Superficial EAC Using VLE

Mayo Clinic

Status: Terminated

Conditions: Esophageal Cancer

Treatments: Diagnostic Test: VLE imaging for staging EAC

Study type: Interventional

Funder types: Other

Identifiers

NCT03385343

17-002723

Details and patient eligibility

About

This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

VLE imaging of stage EAC

Experimental group

Description:

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.

Treatment:

Diagnostic Test: VLE imaging for staging EAC