Brief Title
Photoacoustic Endoscopy in Endometrial Cancer
Official Title
A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer
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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Feasibility of using the device to image endometrial cancer
Condition
Endometrial Cancer
Intervention
Photoacoustic endoprobe
Study Arms / Comparison Groups
Photoacoustic endoscopy
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
0
Start Date
January 2012
Completion Date
December 2012
Primary Completion Date
December 2012
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Israel Zighelboim, MD, ,
Administrative Informations
NCT ID
NCT01498237
Organization ID
201102405
Responsible Party
Sponsor
Study Sponsor
Washington University School of Medicine
Study Sponsor
Israel Zighelboim, MD, Principal Investigator, Washington University School of Medicine
Verification Date
July 2013