Clinical trial NCT01498237: Photoacoustic Endoscopy in Endometrial Cancer
Official title: A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Endometrial Cancer
Benign Neoplasm of Body of Uterus
Keywords: Photoacoustic endoscopy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Feasibility of using the device to image endometrial cancer
timeFrame: 12 months or less
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Israel Zighelboim, MD
role: PRINCIPAL_INVESTIGATOR
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