Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening

• Status: Completed
• Trial end date: 2022-01-20
• Target enrollment: 0
• Participant gender: All

Summary

The investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve functionality, portability and broader use of this device by non-experts, the investigators recently developed a prototype marHRME platform with an automated, augmented reality (AR)-interpretation that provides an overlaid endoscopic + micro-endoscopic view, facilitating diagnosis and biopsy targeting.

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

Details

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

Criteria

Inclusion Criteria:

• Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment including patients with known history of head/neck squamous cell cancer.

• Patients must be >18 years old and able to give informed consent.

• For the provider surveys and interviews, all providers (clinicians, trainees) who are working on the project will be eligible to participate.

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

• Providers will be excluded if they decline participation or otherwise opt out of the proposed research project.