This clinical trial evaluates the use of a mobile augmented reality high-resolution microendoscope (marHRME) after standard of care Lugol's chromoendoscopy in screening for esophageal squamous cell cancer. Lugol's chromoendoscopy is a procedure which uses a staining technique to allow visualization of tissues with an endoscope. While Lugol's chromoendoscopy is the gold standard evaluation for gastrointestinal cancers, specificity is poor and it requires extensive training and experience. The marHRME is a device with automated augmented reality optical biopsy that allows for cancer detection in low to middle income countries with less experienced providers. This clinical trial evaluates the accuracy, efficiency, and acceptability of using the marHRME for esophageal cancer screening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05396781.
PRIMARY OBJECTIVE:
I. To evaluate the marHRME technology in terms of accuracy: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in a single-arm feasibility study (n=50) of high-risk subjects undergoing Lugol’s chromoendoscopy (LCE) followed by marHRME for esophageal squamous cell neoplasia (ESCN) screening.
SECONDARY OBJECTIVE:
I. To evaluate the marHRME technology in terms of performance, efficiency, and impact in a single-arm feasibility study (n=50) of high-risk subjects undergoing Lugol’s chromoendoscopy (LCE) followed by marHRME for ESCN screening.
EXPLORATORY OBJECTIVE:
I. To evaluate the acceptability of the technology among patients and providers.
OUTLINE:
Participants undergo standard of care white light imaging and Lugol's chromoendoscopy. Participants receive proflavine hemisulfate topically and undergo mobile augmented reality high resolution microendoscopy. Patients may undergo biopsy.
After completion of study, participants are followed up at 7 days and then for 1 year.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorSharmila Anandasabapathy
