High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection

Uterine Cancer Clinical Trial

Official title: Use of Fluorescence Imaging and High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection in Patients With Endometrial Cancer

Status Withdrawn

Clinical Trial Summary

The goal of this clinical research study is to learn if imaging (called a hysteroscopy) can be used to help guide tumor removal during a hysterectomy.

Clinical Trial Description

Tissue Collection and Imaging:

If participant is found to be eligible to take part in this study, during their standard-of-care hysterectomy, a tissue sample will be collected. This sample will be used for research and routine testing. Participant will sign a separate consent form for the hysterectomy.

During the hysterectomy, photographs of the tissue will be taken. Participant's private areas will be covered (as much as possible), and a picture of their face will not be taken.

A hysteroscopy will also be performed during participant's surgery. Participant's doctor will discuss the risks of the hysteroscopy with participant and they will be asked to sign a separate consent form. A hysteroscopy allows the doctor to look inside the uterus to see the tissue that is going to be collected for research imaging. This procedure is done with a tool called a hysteroscope, a long thin tube with a camera and a light. The hysteroscope will be inserted though the vagina and up into the uterus. An image will be displayed on a computer screen that is attached to the hysteroscope. The study doctor will use the image on the screen to look at different areas of the uterus to find the location and size of the tumor(s). This image may be recorded for future reference.

After the hysteroscopy, the study doctor will inject a contrast dye (Proflavine Hemisulfate) into participant's uterus to help the doctor see the lesions. A camera will then be used to photograph images of the uterus.

The tissue collection and the imaging will add about 45 minutes to participant's hysterectomy procedure.

Length of Study:

Patient's active participation in this study will be over after surgery.

Follow-Up Call:

About 30 days (+/-7 days) after the surgery, participant will be called and asked how they are doing.

This is an investigational study. The hysteroscope is commercially available and FDA approved for laparoscopic procedures. The use of the hysteroscope in this study is for research purposes only.

Proflavine Hemisulfate (contrast dye) is commercially available and FDA approved for treating umbilical cord stumps. Its use in this study is considered investigational.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cancer
• Uterine Neoplasms

• NCT number: NCT02095847
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Completion date: March 2015