Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

This study is currently recruiting participants.
Verified June 2013 by Swedish Medical Center
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01562106
First received: March 21, 2012
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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 Intervention
Endometrial Cancer
Procedure: Fluorescence-guided sentinel lymph node detection

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 130
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562106

Contacts
Contact: Pamela Paley, MD (206) 965-1700 ppaley@pacificgyn.com

Locations
United States, Washington
Swedish Medical Center Issaquah Campus Recruiting
Issaquah, Washington, United States, 98027
Contact: Pamela Paley, MD    206-965-1700    ppaley@pacific.gyn   
Principal Investigator: Pamela Paley, MD         
Sub-Investigator: Dan Veljovich, MD         
Sub-Investigator: Chirag Shah, MD         
Sub-Investigator: Christina Isacson, MD         
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Pamela Paley, MD    206-965-1700    ppaley@pacificgyn.com   
Principal Investigator: Pamela Paley, MD         
Sub-Investigator: Dan Veljovich, MD         
Sub-Investigator: Chirag Shah, MD         
Sub-Investigator: Christina Isacson, MD         
Pacific Gynecology Specialists Recruiting
Seattle, Washington, United States, 98104
Contact: Pamela Paley, MD    206-965-1700    ppaley@pacificgyn.com   
Principal Investigator: Pamela Paley, MD         
Sub-Investigator: Dan Veljovich, MD         
Sub-Investigator: Chirag Shah, MD         
Sponsors and Collaborators
Swedish Medical Center
Investigators
Principal Investigator: Pamela Paley, MD Swedish Medical Center
  More Information

No publications provided

Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01562106     History of Changes
Other Study ID Numbers: IR 5197
Study First Received: March 21, 2012
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

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:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on April 14, 2014