Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening
Condition: Suspected or Known Squamous Cell Neoplasia; Prior History of Squamous Cell Dysplasia and /or Neoplasia
MeSH terms: Neoplasms; Gastrointestinal Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The investigators' hypothesis is that this mobile device with automated, AR optical biopsy
      diagnoses can efficiently and accurately facilitate endoscopic cancer detection in low to
      middle income countries (LMICs) with less experienced providers and is acceptable to
      providers and patients.

      Objective 1: The investigators' first objective is 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
      esophageal squamous cell neoplasia (ESCN) screening, the investigators will evaluate the
      diagnostic performance and efficiency of this automated optical biopsy device.

      The investigators' main hypothesis is that the marHRME will:

        1. increase the accuracy of Lugol's endoscopy (LCE), other exploratory hypotheses are

        2. increase the accuracy of marHRME among novices and be non-inferior to experts,

        3. increase user confidence among experts and novices and, subsequently,

        4. increase the efficiency and impact of LCE by reducing biopsies and second procedures.

      For performance for marHRME vs. Standard of Care, the investigators will compare the accuracy
      of the marHRME + LCE vs. LCE alone to the gold-standard histopathology (expert GI
      pathologist). For performance of the Machine vs. Man, the investigators will compare accuracy
      of the marHRME software read to novice and expert clinicians' subjective read to
      gold-standard histopathology. For clinician confidence and clinical impact, the investigators
      will determine the clinician's confidence level in the software diagnosis and the potential
      clinical impact of this diagnosis among novice and expert endoscopists using marHRME.

      Objective 2: The investigators' secondary objective is to evaluate the acceptability of the
      technology among patients and providers. All patients participating in the study will be
      invited to participate in a brief (20 min) interviewer-administered survey prior to
      undergoing endoscopy to assess attitudes and barriers to marHRME, and a follow-up interview
      (7 days post-procedure) to determine experiences and acceptability. Informed consent and the
      initial interview will be conducted in a private clinic room by trained study staff from the
      Brazilian team using a brief Portuguese-language survey. The follow-up interview will occur
      by phone, after a routine follow-up call by clinical staff.

      The endoscopists and trainees participating in the feasibility study will be invited to
      participate in a series of questionnaires and in- depth interviews administered at different
      time points of the study to assess provider acceptance. Informed consent will be obtained
      prior to the first interview. Clinicians will answer a brief questionnaire to assess
      acceptance of marHRME prior to undergoing raining, after training, and after conducting 25
      procedures. After 25 procedures, endoscopists and trainees will participate in a 30- minute
      semi-structured interview to assess marHRME experience. The interviews will be audio
      recorded, professionally transcribed, and translated (Portuguese to English) for coding and
      analysis.
    

Intervention name(s): Proflavine; Mobile, Augmented High Resolution Microendoscope
Intervention type(s): Drug; Device
Intervention description(s): 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.; The marHRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.
Other intervention name(s): proflavine hemisulfate; marHRME
Intervention MeSH terms: Proflavine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Squamous cell neoplasia; Proflavine; Lugol's chromoendoscopy