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Photoacoustic Endoscopy in Endometrial Cancer

Primary Purpose

Endometrial Cancer, Benign Neoplasm of Body of Uterus

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Photoacoustic endoprobe
Photoacoustic endoscopy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Cancer focused on measuring Photoacoustic endoscopy

Eligibility Criteria

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

Inclusion Criteria:

  • Women diagnosed with benign gynecologic pathology (N=10) or biopsy proven endometrial cancer (N=10) who will undergo hysterectomy.
  • Participants must be ≥ 18 years of age.
  • Subjects of reproductive potential must have a negative pregnancy test prior to study photoacoustic endoscopy procedure and hysterectomy.
  • Subjects must be able understand and willing to sign a written informed consent form.

Exclusion Criteria:

  • Subjects with contraindications for general anesthesia or hysterectomy.
  • Subjects with evidence of active pelvic inflammatory disease or purulent cervicitis.
  • Subjects with prior endometrial ablation procedures.
  • Gross tumoral involvement of the cervix or lower genital tract precluding cervical dilatation and endometrial sounding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Photoacoustic endoscopy

    Arm Description

    This is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.

    Outcomes

    Primary Outcome Measures

    Feasibility of using the device to image endometrial cancer
    Feasibility of using this novel device to image endometrial cancer is our primary objective. The frequency of success in obtaining images, overall and per group, will be presented and binomial success rates with 95% confidence interval estimates will be calculated. Besides the overall success rates, graphical and tabular summaries of the feasibility across patient demographic and clinical characteristics will be created.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 12, 2011
    Last Updated
    July 9, 2013
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01498237
    Brief Title
    Photoacoustic Endoscopy in Endometrial Cancer
    Official Title
    A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Need to obtain IDE prior to commencement of study
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this research study is to evaluate whether a new technology called intrauterine photoacoustic endoscopy (PAE) can be used to evaluate the inner lining of the uterus.
    Detailed Description
    The investigators will evaluate whether this technology can be used and also try to obtain photoacoustic images and functional data (oxygen contents, blood vessel characteristics, etc) of the uterine lining to assess its appearance in women with and without cancer of the endometrium. Currently, it is difficult for physicians to know whether or not tumors of the endometrium have invaded and spread to other organs without performing an extended surgery called a staging operation (removal of the lymph nodes or glands that drain the uterus to assess under the microscope whether or not the cancer has spread). Our long term goal is to use this new photoacoustic (PA) technology to improve detection of occult metastatic disease. Occult disease is defined as tumor which cannot be seen without the use of imaging techniques. and possibly avoid the need of extended operations. All of this could result in better care for patients with endometrial cancer and other gynecologic problems.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Cancer, Benign Neoplasm of Body of Uterus
    Keywords
    Photoacoustic endoscopy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Photoacoustic endoscopy
    Arm Type
    Experimental
    Arm Description
    This is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.
    Intervention Type
    Device
    Intervention Name(s)
    Photoacoustic endoprobe
    Other Intervention Name(s)
    There are no other interventions.
    Intervention Description
    The PAE assessment will be performed in the operating room following strict sterile technique. PAE is performed immediately prior to the planned surgery. Participants are prepped following standard protocol. Length of the endometrial cavity is determined by a uterine sound. Endocervix is dilated as needed to allow passage of the PAE probe. The PAE probe will be advanced to the uterine fundus. Images will be obtained during withdrawal of the PAE probe from fundus to the os. Recorded images will allow computer assisted image analysis and functional measurements to be performed. Duration and difficulty of the procedure will be recorded. Comments and complications will be specifically noted.
    Intervention Type
    Procedure
    Intervention Name(s)
    Photoacoustic endoscopy
    Other Intervention Name(s)
    There are no other interventions.
    Intervention Description
    Photoacoustic endoscopy probe will be inserted into the endometrial canal to the uterine fundus and images will be obtained during the withdrawal of the probe from the fundus to the endocervical os.
    Primary Outcome Measure Information:
    Title
    Feasibility of using the device to image endometrial cancer
    Description
    Feasibility of using this novel device to image endometrial cancer is our primary objective. The frequency of success in obtaining images, overall and per group, will be presented and binomial success rates with 95% confidence interval estimates will be calculated. Besides the overall success rates, graphical and tabular summaries of the feasibility across patient demographic and clinical characteristics will be created.
    Time Frame
    12 months or less

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women diagnosed with benign gynecologic pathology (N=10) or biopsy proven endometrial cancer (N=10) who will undergo hysterectomy. Participants must be ≥ 18 years of age. Subjects of reproductive potential must have a negative pregnancy test prior to study photoacoustic endoscopy procedure and hysterectomy. Subjects must be able understand and willing to sign a written informed consent form. Exclusion Criteria: Subjects with contraindications for general anesthesia or hysterectomy. Subjects with evidence of active pelvic inflammatory disease or purulent cervicitis. Subjects with prior endometrial ablation procedures. Gross tumoral involvement of the cervix or lower genital tract precluding cervical dilatation and endometrial sounding.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Israel Zighelboim, MD
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Links:
    URL
    http://www.siteman.wustl.edu
    Description
    Alvin J.Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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