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Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562106
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Swedish Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: Fluorescence-guided sentinel lymph node detection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
Study Start Date : February 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : August 2016

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.

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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01562106

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United States, Washington
Swedish Medical Center Issaquah Campus
Issaquah, Washington, United States, 98027
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
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Principal Investigator: Pamela Paley, MD Swedish Medical Center
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Responsible Party: Swedish Medical Center Identifier: NCT01562106    
Other Study ID Numbers: IR 5197
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Swedish Medical Center:
Cancer of Endometrium
Cancer of the Endometrium
Carcinoma of Endometrium
Endometrial Carcinoma
Endometrium Cancer
Neoplasms, Endometrial
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases