Know Cancer

or
forgot password

A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer


N/A
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer, Benign Neoplasm of Body of Uterus

Thank you

Trial Information

A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of using the device to image endometrial cancer

Outcome 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.

Outcome Time Frame:

12 months or less

Safety Issue:

Yes

Principal Investigator

Israel Zighelboim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

201102405

NCT ID:

NCT01498237

Start Date:

January 2012

Completion Date:

December 2012

Related Keywords:

  • Endometrial Cancer
  • Benign Neoplasm of Body of Uterus
  • Photoacoustic endoscopy
  • Neoplasms
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Brain Neoplasms
  • Adenoma

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110