Overview

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)