Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia

Cervical Cancer Clinical Trial

Official title: Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

Clinical Trial Description

If you are found to be eligible to take part in this study, you will first have your scheduled VIA and colposcopy. The study doctor will tell you more about this procedure. You will then have proflavine hemisulfate solution (contrast dye) applied to your 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 should add about 10 minutes to the total procedure time. The HRME images will be stored in an electronic database and used for research. The images will be deidentified and only the MD Anderson staff will have access. This data will be stored in the database indefinitely (forever). Any abnormal areas found during the VIA and/or colposcopy will be biopsied as part of your standard of care using very small forceps (a medical tool that is like tongs). If the exam shows no abnormalities, a normal area will be biopsied. The study doctor will talk to you about the results of the HRME imaging, colposcopy, and biopsy/ies. There will be no change to the planned standard-of-care colposcopy and biopsy. Researchers will also collect information from your medical record about the colposcopy, surgery, the status of the disease, and demographics (such as your age). Follow-Up: About 1 month after the study procedure, the study staff will contact you by phone to ask how you are doing. The 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. Proflavine hemisulfate is not FDA approved or commercially available. The HRME device is not FDA approved or commercially available. Both are currently being used for research purposes only. Up to 800 participants will be enrolled in this study. Up to 400 will take part at MD Anderson and up to 400 will take part at the Harris Health System. ;

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

• NCT number: NCT02420665
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Early Phase 1
• Start date: September 23, 2015
• Completion date: May 14, 2021