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Withdrawn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
About this trial
This is an interventional diagnostic trial for Endometrial Cancer focused on measuring Photoacoustic endoscopy
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.
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
NCT ID
NCT01498237
First Posted
December 12, 2011
Last Updated
July 9, 2013
Sponsor
Washington University School of Medicine
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Withdrawn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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Photoacoustic Endoscopy in Endometrial Cancer
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