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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Cervix Carcinoma

Intervention / Treatment
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* Drug: Proflavine
* Procedure: High-Resolution Microendoscopy (HRME) Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Resolution Microendoscopy (HRME)<br>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. | Drug: Proflavine<br>* 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.<br>Procedure: High-Resolution Microendoscopy (HRME) Imaging<br>* in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.<br>* Other names: HRME;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization | Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervix Carcinoma, AIS, Cervical adenocarcinoma in situ, Cervical intraepithelial neoplasia, CIN, microinvasive carcinoma of the cervix, cold knife cone of the cervix, CKC, High-Resolution Microendoscopy, HRME, Proflavine