CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 163 enrolled
Drug / intervention
Proflavine Hemisulfate +2 moredrug
Likely dose
Proflavine Hemisulfate 10 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04563754
NCT04563754Phase 2Completed
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The Effectiveness of High Resolution Microendoscopy (HRME) in High Grade Intraepithelial Lesions (HSIL) Diagnosis for People Living With HIV

Baylor College of Medicine·interventional·Posted Sep 24, 2020·Updated Apr 23, 2025

In Brief

A Phase 2 clinical trial evaluating mHRME (Mobile High resolution microendoscope), Proflavine Hemisulfate, and 1 other intervention for Anal High Grade Squamous Intraepithelial Lesion. Completed, enrolled 163 participants across 3 sites.

Detailed Summary

The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated with neoplasia. The investigators' central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of high-resolution anoscopy(HRA)-guided biopsy, thus facilitating usage by less-experienced clinicians in community-based or low-resource settings. To validate this, the investigators will conduct a study to determine the efficiency and diagnostic characteristics of the mHRME 'optical biopsy' approach versus the current standard of HRA-based tissue biopsy. Successful results will allow for improved efficacy and resource utilization for cancer screening in people living with HIV for anal cancer and other epithelial cancers including the cervix, oral cavity, bladder, and GI tract.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal High Grade Squamous Intraepithelial Lesion
CountriesUnited States
CollaboratorsIcahn School of Medicine at Mount Sinai, William Marsh Rice University, University of California, San Francisco, The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center, Medical University of South Carolina

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 24, 2020
Enrollment StartJul 30, 2019
Primary CompletionMar 28, 2024
Study CompletionMar 28, 2025
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 5.8 years ago

Interventions

mHRME (Mobile High resolution microendoscope)other

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 Hemisulfatedrug

Contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)) to use with the mHRME

High resolution anoscopyother

Standard of care (SOC) HRA with Lugol's iodine will be performed.