Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Swedish Medical Center
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01562106
First received: March 21, 2012
Last updated: September 17, 2014
Last verified: September 2014

March 21, 2012
September 17, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer. [ Time Frame: Average expected time of 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562106 on ClinicalTrials.gov Archive Site
Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation. [ Time Frame: Average expected time of 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Endometrial Cancer
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.
Experimental: ICG Dye
Fluorescence-guided sentinel lymph node detection
Intervention: Procedure: Fluorescence-guided sentinel lymph node detection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Pamela Paley, MD (206) 965-1700 ppaley@pacificgyn.com
United States
 
NCT01562106
IR 5197
No
Swedish Medical Center
Swedish Medical Center
Not Provided
Principal Investigator: Pamela Paley, MD Swedish Medical Center
Swedish Medical Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP