Photoacoustic Endoscopy in Endometrial Cancer

This study has been withdrawn prior to enrollment.
(Need to obtain IDE prior to commencement of study)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01498237
First received: December 12, 2011
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Benign Neoplasm of Body of Uterus
Device: Photoacoustic endoprobe
Procedure: Photoacoustic endoscopy
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Feasibility of using the device to image endometrial cancer [ Time Frame: 12 months or less ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photoacoustic endoscopy
This is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.
Device: Photoacoustic endoprobe
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.
Other Name: There are no other interventions.
Procedure: Photoacoustic endoscopy
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.
Other Name: There are no other interventions.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01498237

Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Israel Zighelboim, MD Washington University Early Recognition Center
  More Information

Additional Information:
Publications:
American National Standards Institute. Laser Institute of America.American National Standards for Safe Use of Lasers ANSI Z136.1 - 2007. American National Standards Institute, Inc. New York NY, 2007

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01498237     History of Changes
Other Study ID Numbers: 201102405
Study First Received: December 12, 2011
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Photoacoustic endoscopy

Additional relevant MeSH terms:
Neoplasms
Endometrial Neoplasms
Brain Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014