Status:
COMPLETED
Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Cervix Carcinoma
Eligibility:
FEMALE
21-64 years
Phase:
NA
Brief 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 biops...
Detailed Description
If you agree to take part in this study, after you are in the operating room and under general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the cervix. Images will be ...
Eligibility Criteria
Inclusion
- Any woman with a confirmed preoperative diagnosis of cervical AIS, including co-existing squamous CIN and/or microinvasive cancer
- Women undergoing cold knife cone (CKC) of the cervix at MD Anderson
- Negative pregnancy test for women of child-bearing potential
- Women who are \>/= 21 years of age and \< 65 years of age
- Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)
Exclusion
- Women \< 21 years of age and \>/= 65 years of age
- Women with a known allergy to proflavine or acriflavine
- Women who are pregnant or nursing
- Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
Key Trial Info
Start Date :
October 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02206048
Start Date
October 2 2015
End Date
April 21 2021
Last Update
July 25 2022
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030