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Completed

NCT Number: NCT01562106

Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Swedish Medical Center Issaquah Campus, Issaquah, Washington, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorescence-guided sentinel lymph node detection

Procedure

During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Swedish Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Mar 23, 2012
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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