Gastric In Vivo Study

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of gastric neoplasia (high grade dysplasia or cancer). As part of an NCI-funded RO1, the investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a "red flag" for microendoscopic imaging of small areas. In prior ex vivo evaluations of surgical and endoscopic specimens, the investigators have identified the optical settings and illumination wavelengths that are complementary to white-light imaging and enhance superficial mucosal and vascular changes associated with neoplasia. Based on this initial testing, vital-dye enhanced fluorescence imaging (VFI) and imaging with High Resolution Microendoscope (HRME) have been identified as modalities that may be complementary to white-light imaging. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance and detection of gastric neoplasia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Susana Gonzalez
• Collaborator: William Marsh Rice University
• Treatments: Proflavine

Criteria

Inclusion Criteria:

• patients with high grade dysplasia in the stomach and known or suspected cancer of the stomach undergoing endoscopic surveillance

• at least 18 years of age

Exclusion Criteria:

• subjects who report an allergy to Proflavine