163
Participants
Start Date
July 30, 2019
Primary Completion Date
March 28, 2024
Study Completion Date
March 28, 2025
mHRME (Mobile High resolution microendoscope)
"Standard of care (SOC) high-resolution anoscopy (HRA) with Lugol's iodine will be performed. The unstained (abnormal) area will be evaluated with mHRME for optical biopsy diagnosis:~1. contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)),~2. the mHRME will then be inserted and imaging of abnormal tissues will be performed. This will add 2 to 6 minutes per procedure.~This is a single-arm study where all subjects will receive both SOC HRA and experimental mHRME imaging."
Proflavine Hemisulfate
Contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)) to use with the mHRME
High resolution anoscopy
Standard of care (SOC) HRA with Lugol's iodine will be performed.
Icahn School of Medicine at Mount Sinai, New York
Baylor College of Medicine, Houston
M.D. Anderson Cancer Center, Houston
Icahn School of Medicine at Mount Sinai
OTHER
William Marsh Rice University
OTHER
University of California, San Francisco
OTHER
The University of Texas Health Science Center, Houston
OTHER
M.D. Anderson Cancer Center
OTHER
Medical University of South Carolina
OTHER
Baylor College of Medicine
OTHER