Photoacoustic Endoscopy in Endometrial Cancer

Early Phase 1

Withdrawn

• Conditions: Endometrial Cancer; Benign Neoplasm of Body of Uterus
• Interventions: Device: Photoacoustic endoprobe; Procedure: Photoacoustic endoscopy

• Registration Number: NCT01498237
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photoacoustic endoscopy	Photoacoustic endoprobe	This is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.
Photoacoustic endoscopy	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of using the device to image endometrial cancer	12 months or less	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.