High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection

April 7, 2015 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Any patient with a confirmed preoperative diagnosis of endometrial cancer
  2. Histologic subtype limited to endometrioid adenocarcinoma
  3. Patients with any grade of endometrial cancer (histologically confirmed)
  4. Patients with no contraindications to surgery
  5. Patients scheduled for hysterectomy by laparotomy, laparoscopy, or robotic surgery
  6. Patient must have had a preoperative MRI within 30 days of surgery at MD Anderson Cancer Center. Outside imaging will be allowed provided that staff radiologist at MD Anderson consider the quality of the study optimal to make a definitive diagnosis regarding myometrial invasion
  7. Patients must have <50% myometrial invasion on preoperative MRI
  8. Patients must have disease confined to either anterior or posterior wall of the uterus
  9. Ability to understand and the willingness to sign a written Informed Consent Document (ICD).

Exclusion Criteria:

  1. Patients with invasive uterine disease (>50% invasion) by preoperative MRI
  2. Patients with a diagnosis of leiomyomata affecting the endometrium
  3. Patients with a prior history of endometrial ablation
  4. Patients with multifocal disease within the uterus on preoperative MRI
  5. Patients with polypoid tumors protruding through the endocervical canal
  6. Patients with histology other than endometrioid adenocarcinoma
  7. Patients who have undergone a prior D&C for diagnosis of endometrial cancer
  8. Patients with exposure to metformin within 6 months of endometrial cancer diagnosis or at the time of diagnosis
  9. Patients < 18 years of age
  10. Patients with a known allergy to proflavine or acriflavine
  11. Patients that are pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hysteroscope Imaging
All patients entered in study will undergo cervical dilation after induction of general anesthesia. Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor. Location and size of tumor documented. White-light images obtained using the High-Resolution Microendoscopy (HRME) camera introduced through the hysteroscope. Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)). A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera. The resectoscope will then be used to remove all tumor as guided through HRME images. The entire imaging and tumor resection process is estimated to take 45 minutes or less.
Procedure: High-Resolution Microendoscopy Imaging
Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor. Location and size of tumor documented. White-light images obtained using the HRME camera introduced through the hysteroscope. Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)). A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera.
Other Names:
  • HRME
Drug: Proflavine
After hysteroscopy with HRME camera, uterine cavity infused with 10 mL of Proflavine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Residual Disease in Hysterectomy Specimen
Time Frame: 1 day
Descriptive statistics used to summarize the expression in tumor tissue and in normal tissue for each of the molecular markers assessed, as well as the difference in tumor and normal tissue within patient. Paired t-test used to compare the tumor and normal tissue with respect to the mean difference in expression of each marker, pairing tumor and normal tissue on patient. Boxplots used to illustrate the distribution of the difference in expression in tumor and normal tissue for each marker.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Ovarian Spore

Investigators

  • Principal Investigator: Pedro Ramirez, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-1080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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