Photoacoustic Endoscopy in Endometrial Cancer

NCT01498237 | Withdrawn Early Phase 1 DMC

• 1 other identifier: 201102405
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial Cancer; Benign Neoplasm of Body of Uterus

Keywords

Photoacoustic endoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months or less

Study Arms (1)

Photoacoustic endoscopy

EXPERIMENTAL

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

Device: Photoacoustic endoprobe; Procedure: Photoacoustic endoscopy

Interventions

Photoacoustic endoprobe DEVICE

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.

Also known as: There are no other interventions.

Photoacoustic endoscopy

Photoacoustic endoscopy PROCEDURE

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.

Also known as: There are no other interventions.

Photoacoustic endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

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  BACKGROUND

Related Links

• Alvin J.Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Israel Zighelboim, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 11, 2013

Record last verified: 2013-07