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High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection

Primary Purpose

Uterine Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
High-Resolution Microendoscopy Imaging
Proflavine
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cancer focused on measuring Uterine Cancer, Endometrial cancer, Hysterectomy, Hysteroscopy, High-resolution microendoscopy, HRME, Hysteroscopic-guided resection, Proflavine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hysteroscope Imaging

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Absence of Residual Disease in Hysterectomy Specimen
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2014
    Last Updated
    April 7, 2015
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    Ovarian Spore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02095847
    Brief Title
    High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection
    Official Title
    Use of Fluorescence Imaging and High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection in Patients With Endometrial Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    Ovarian Spore

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterine Cancer
    Keywords
    Uterine Cancer, Endometrial cancer, Hysterectomy, Hysteroscopy, High-resolution microendoscopy, HRME, Hysteroscopic-guided resection, Proflavine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hysteroscope Imaging
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    High-Resolution Microendoscopy Imaging
    Other Intervention Name(s)
    HRME
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Proflavine
    Intervention Description
    After hysteroscopy with HRME camera, uterine cavity infused with 10 mL of Proflavine.
    Primary Outcome Measure Information:
    Title
    Absence of Residual Disease in Hysterectomy Specimen
    Description
    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.
    Time Frame
    1 day

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Any patient with a confirmed preoperative diagnosis of endometrial cancer Histologic subtype limited to endometrioid adenocarcinoma Patients with any grade of endometrial cancer (histologically confirmed) Patients with no contraindications to surgery Patients scheduled for hysterectomy by laparotomy, laparoscopy, or robotic surgery 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 Patients must have <50% myometrial invasion on preoperative MRI Patients must have disease confined to either anterior or posterior wall of the uterus Ability to understand and the willingness to sign a written Informed Consent Document (ICD). Exclusion Criteria: Patients with invasive uterine disease (>50% invasion) by preoperative MRI Patients with a diagnosis of leiomyomata affecting the endometrium Patients with a prior history of endometrial ablation Patients with multifocal disease within the uterus on preoperative MRI Patients with polypoid tumors protruding through the endocervical canal Patients with histology other than endometrioid adenocarcinoma Patients who have undergone a prior D&C for diagnosis of endometrial cancer Patients with exposure to metformin within 6 months of endometrial cancer diagnosis or at the time of diagnosis Patients < 18 years of age Patients with a known allergy to proflavine or acriflavine Patients that are pregnant or nursing
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pedro Ramirez, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mdanderson.org
    Description
    University of Texas MD Anderson Cancer Center Website

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