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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Cervix Carcinoma

Treatments: Procedure: High-Resolution Microendoscopy (HRME) Imaging; Drug: Proflavine

Study type: Interventional

Funder types: Other

Identifiers

NCT02206048

14037870 (Other Identifier)

NCI-2014-01790 (Registry Identifier)

2013-0885

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 9 patients

Sex: Female

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

High-Resolution Microendoscopy (HRME)

Experimental group

Description:

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.

Treatment:

Drug: Proflavine

Procedure: High-Resolution Microendoscopy (HRME) Imaging