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

Cervix Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206048
• Other study ID #: 2013-0885
• Secondary ID: 14037870NCI-2014
• Status: Completed
• Phase: N/A
• Start date: October 2, 2015
• Est. completion date: April 21, 2021

Study information

• Verified date: July 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma in Situ
• Carcinoma
• Cervix Carcinoma

Intervention

Drug:
• Proflavine
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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   University of Texas MD Anderson Cancer Center Website