Official Title
Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
Phase
Early Phase 1Lead Sponsor
Baylor UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Squamous Cell CancerIntervention/Treatment
proflavine ...Study Participants
70The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides > 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.
1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)
Inclusion Criteria: known or suspected squamous cell neoplasia 18 years or older