Overview

Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix

Status:
Completed
Trial end date:
2021-04-21
Target enrollment:
0
Participant gender:
Female
Summary
The goal of this clinical research study is to learn if it is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Proflavine
Criteria
Inclusion Criteria:

1. Any woman with a confirmed preoperative diagnosis of cervical AIS, including
co-existing squamous CIN and/or microinvasive cancer

2. Women undergoing cold knife cone (CKC) of the cervix at MD Anderson

3. Negative pregnancy test for women of child-bearing potential

4. Women who are >/= 21 years of age and < 65 years of age

5. 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 and >/= 65 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)