Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
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|ClinicalTrials.gov Identifier: NCT02206048|
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervix Carcinoma||Drug: Proflavine Procedure: High-Resolution Microendoscopy (HRME) Imaging||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix|
|Actual Study Start Date :||October 2, 2015|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: High-Resolution Microendoscopy (HRME)
Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.
0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.
Procedure: High-Resolution Microendoscopy (HRME) Imaging
in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.
Other Name: HRME
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206048
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Kathleen Schmeler, MD||M.D. Anderson Cancer Center|