The Effectiveness of High Resolution Microendoscopy for People Living With HIV

NCT04563754 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: H-44616 Anal HRME
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)

  The primary outcome of this study is to measure the operating characteristics including SN, SP, PPV and NPV comparing the physician- and algorithm- guided HRME-based image compared to the Lugol's- guided physician diagnosis of HSIL during HRA. Gold standard consensus pathology was used and pathology data needs to be obtained, verified, and entered.

  1 day

Secondary Outcomes (2)

• Procedure Efficiency

  1 day

• Procedure Time

  1 day

Study Arms (1)

mHRME

EXPERIMENTAL

5-10 ml of proflavine hemisulfate (0.01%) will be applied on the anal epithelium. The mHRME will then be inserted and imaging of abnormal tissues will be performed. This is a single-arm study where all subjects will receive both standard of care HRA (High resolution anoscopy) and experimental mHRME imaging.

Diagnostic Test: mHRME (Mobile High resolution microendoscope); Drug: Proflavine Hemisulfate; Diagnostic Test: High resolution anoscopy

Interventions

mHRME (Mobile High resolution microendoscope) DIAGNOSTIC_TEST

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.

mHRME

Proflavine Hemisulfate DRUG

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

mHRME

High resolution anoscopy DIAGNOSTIC_TEST

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

mHRME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consentable patients with documented HIV disease
• Either: 1) previously documented HSIL or 2) abnormal anal cytology within the past 2 years
• Ages 18 years and older
• Seen at the Baylor-affiliated Thomas Street Clinic (TSC), Mount Sinai Hospital and affiliated clinics

You may not qualify if:

• Unable to undergo routine anoscopy
• Allergy or prior reaction to the fluorescent contrast agent Proflavine or Iodine
• Unable to give informed consent
• Current or prior history of Invasive Anal Cancer
• Known permanent or irreversible bleeding disorder, or other hematologic disorder that in the opinion of the investigator would place the patient at increased risk for adverse outcome from the procedure
• Pregnancy

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• William Marsh Rice University: collaborator
• University of California, San Francisco: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• M.D. Anderson Cancer Center: collaborator
• Medical University of South Carolina: collaborator

Study Sites (3)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Brenes D, Kortum A, Carns J, Mutetwa T, Schwarz R, Liu Y, Sigel K, Richards-Kortum R, Anandasabapathy S, Gaisa M, Chiao E. Automated In Vivo High-Resolution Imaging to Detect Human Papillomavirus-Associated Anal Precancer in Persons Living With HIV. Clin Transl Gastroenterol. 2023 Feb 1;14(2):e00558. doi: 10.14309/ctg.0000000000000558.

  PMID: 36729506 DERIVED

MeSH Terms

Interventions

Proflavine

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Sharmila Anandasabapathy
• Organization: Baylor College of Medicine

Sharmila.Anandasabapathy@bcm.edu

713-798-8105

Study Officials

• Sharmilla Anandasabapathy, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Elizabeth Y Chiao, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be used in this study.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: This is a single-arm study where all subjects will receive both standard of care HRA (High resolution anoscopy) and experimental mHRME imaging.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: September 24, 2020
• Study Start: July 30, 2019
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2025
• Last Updated: April 23, 2025
• Results First Posted: April 23, 2025

Record last verified: 2025-04

Locations

US (3)