The Effectiveness of High Resolution Microendoscopy for People Living With HIV

• Status: Completed
• Trial end date: 2024-03-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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