What side effects are associated with this type of intervention?

Common treatments for Anal Squamous Intraepithelial Lesions (ASIL) include high-resolution anoscopy (HRA)-guided biopsy and other imaging techniques like the Mobile High-Resolution Microendoscope (mHRME). These procedures are generally well-tolerated but can cause side effects such as discomfort, bleeding, and infection at the biopsy site. Less invasive imaging techniques like mHRME aim to reduce these risks by providing detailed cellular images without the need for extensive tissue removal. However, any procedure involving manipulation of the anal epithelium can potentially lead to temporary pain and minor complications.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Anal Squamous Intraepithelial Lesions (ASIL) that utilize a diagnostic approach similar to the Mobile High-Resolution Microendoscope (mHRME). The mHRME is an investigational tool designed to provide detailed subcellular imaging to identify neoplastic changes, which is not a common feature of existing FDA-approved treatments for ASIL. Most approved treatments focus on therapeutic interventions rather than advanced diagnostic imaging.

What other types of research exist?

Promising novel alternatives to mHRME for ASIL patients include: 1) High-Resolution Anoscopy (HRA) with advanced imaging techniques, 2) Multiparametric Magnetic Resonance Imaging (mpMRI), and 3) Optical Coherence Tomography (OCT). These technologies provide detailed imaging and have shown potential in improving diagnostic accuracy for neoplastic changes.

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mHRME (Mobile High resolution microendoscope) for Anal Squamous Intraepithelial Lesions

Phase 1 & 2

Waitlist Available

Led By Sharmilla Anandasabapathy, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a portable device that takes detailed pictures of cells to help detect cancer in people living with HIV. The goal is to see if this new method is better than current techniques for diagnosing cancer.

Who is the study for?

This trial is for adults over 18 with HIV who have had abnormal anal cytology or documented HSIL in the past two years. They must be patients at specific clinics and able to consent. Excluded are those allergic to Proflavine or Iodine, with bleeding disorders, a history of invasive anal cancer, pregnant women, or those unable to undergo anoscopy.

What is being tested?

The study tests a new portable device (mHRME) against standard high-resolution anoscopy (HRA) for detecting precancerous changes in the anus. The mHRME provides detailed images and aims to improve screening efficiency and accessibility for people living with HIV.

What are the potential side effects?

Potential side effects may include reactions to the fluorescent contrast agent Proflavine used during imaging such as local irritation or allergic reaction. There's also a general risk associated with biopsies like bleeding or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Performance characteristics: Sensitivity (SN), Specificity (SP), positive predictive value (PPV) and negative predictive values (NPV)

Secondary study objectives

Procedure efficiency

Procedure time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: mHRMEExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mHRME (Mobile High resolution microendoscope)

2019

Completed Phase 2

~170

Proflavine Hemisulfate

2009

Completed Phase 2

~210

High resolution anoscopy

2014

Completed Phase 2

~680

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Anal Squamous Intraepithelial Lesions (ASIL) include high-resolution anoscopy (HRA)-guided biopsy and emerging technologies like the Mobile High-Resolution Microendoscope (mHRME). HRA-guided biopsy involves visually inspecting the anal epithelium and taking tissue samples for pathological examination, which helps in identifying and treating precancerous lesions early. The mHRME, on the other hand, provides real-time, subcellular images of the anal epithelium, allowing for immediate identification of neoplastic changes without the need for extensive tissue sampling. This optical approach can increase diagnostic efficiency and reduce the need for invasive procedures, which is particularly beneficial for patients in low-resource settings. These treatments are crucial as they enable early detection and management of ASIL, potentially preventing progression to anal cancer.

High-resolution microendoscopy: a point-of-care diagnostic for cervical dysplasia in low-resource settings.