NCT02206048

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cervix Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-10-02
• Primary completion: 2021-04-21
• Completion: 2021-04-21
• First posted: 2014-08-01
• Last updated: 2022-07-25
• Results posted: 2022-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study