Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia

• Status: Completed
• Trial end date: 2021-05-14
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Acetic Acid; Proflavine; Retinol acetate

Criteria

Inclusion Criteria:

1. Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of cervical dysplasia (CIN or AIS)

2. Women of childbearing potential must have a negative pregnancy test

3. Women who are at least 21 years of age or older

4. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

Exclusion Criteria:

1. Women < 21 years of age

2. Women with a known allergy to proflavine or acriflavine

3. Women who are pregnant or nursing

4. Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)