Overview
Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
Status:
Completed
Completed
Trial end date:
2021-04-21
2021-04-21
Target enrollment:
0
0
Participant gender:
Female
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/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer CenterTreatments:
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)