Overview

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.