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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 biopsy of the cervix. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

Detailed Summary:

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 collected with the probe from the HRME device. The HRME probe is a long thin tube with a camera at the tip. This probe will be applied to the cervix and images obtained. These images will be used for research. This should add about 10 minutes to the total time you are in the operating room.

There will be no change to the planned standard-of-care colposcopy and biopsy.

Follow-Up:

A member of the research team will call you within 30 days after the procedure to ask how you are feeling and if you are having any symptoms. This call should last about 5 minutes.

Length of Study:

Your active participation in this study will be over after the biopsy.

This is an investigational study. 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.


Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Feasibility of Acquiring in-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization [ Time Frame: 1 day ]

Methodology determined feasible if in-vivo HRME images are acquired in 18 of the 20 patients enrolled in the study.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adenocarcinoma In-Situ (AIS) Distinguished from Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging [ Time Frame: 1 day ]

AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance.


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: July 30, 2014
Date Started: October 2015
Date Completion:
Last Updated: December 1, 2016
Last Verified: December 2016