High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides >1000X magnified images of the esophageal mucosa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anandasabapathy, Sharmila, M.D.
• Collaborators: Baylor College of Medicine; William Marsh Rice University
• Treatments: Proflavine

Criteria

Inclusion Criteria:

All inclusive outpatients undergoing routine (standard of care) Lugol's chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing patients referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group.

Exclusion Criteria:

• Allergy or prior reaction to the fluorescent contrast agent proflavine

• Patients who are unable to give informed consent

• Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy

• Patient unable to undergo routine endoscopy with biopsy:

• women who are pregnant or breastfeeding

• prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0

• inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues