Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

November 16, 2016 updated by: Swedish Medical Center

A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment

The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In many cancer types, such as breast cancer and melanoma, sentinel node assessment has become the standard of care surgical treatment. Sentinel nodes are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. Removal of a sentinel node for examination accurately predicts whether the cancer has spread to other nodes further along in the nodal chain. Fluorescence imaging with ICG dye (Indocyanine Green) has been used to detect lymph nodes in patients with gastric, colorectal and breast cancer. To date, the use of this technique in endometrial cancer has not been reported.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Issaquah, Washington, United States, 98027
        • Swedish Medical Center Issaquah Campus
      • Seattle, Washington, United States, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Biopsy proven endometrial carcinoma
  • Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care
  • Must be 18 years of age and older
  • Must be able to comply with all the study procedures

Exclusion Criteria:

  • Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin > 1.5 times normal, and/or SGOT > 2 times normal
  • Uremia, serum creatinine > 2.0 mg/dl
  • Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes
  • Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage
  • Pregnant
  • Currently participating in a drug, biologic and/or device treatment study
  • Any medical condition that would normally prevent someone from receiving general anesthesia or undergoing standard surgical procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG Dye
Fluorescence-guided sentinel lymph node detection
Procedure: Fluorescence-guided sentinel lymph node detection
During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
Time Frame: Average expected time of 12 weeks
Average expected time of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
Time Frame: Average expected time of 12 weeks
In cancer, "upstaging" is changing the stage used to describe a patient's cancer from a lower stage (less extensive) to a higher stage (more extensive). The sentinel lymph nodes removed during the flourescence guided surgery will be examined microscopically to determine how often upstaging occurred.
Average expected time of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Medical Center

Investigators

  • Principal Investigator: Pamela Paley, MD, Swedish Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR 5197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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