The Effectiveness of High Resolution Microendoscopy for People Living With HIV

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.

Conditions

• Anal High Grade Squamous Intraepithelial Lesion

Interventions

DIAGNOSTIC_TEST

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.

DRUG

Proflavine Hemisulfate

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

DIAGNOSTIC_TEST

High resolution anoscopy

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• William Marsh Rice University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Sharmilla Anandasabapathy, MD · Baylor College of Medicine

• Elizabeth Y Chiao, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-30

Primary Completion

2024-03-28

Completion

2025-03-28

FDA Drug

Yes

Countries

• United States

Study Locations