Brief Title
Lymph Node Mapping in Patients With Endometrial Cancer
Official Title
Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue and Indocyanine Green Dyes With Fluorescence Imaging
Brief Summary
This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph
node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer
staging and treatment.
Detailed Description
PRIMARY OBJECTIVE:
I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in
endometrial cancer to predict nodal metastasis.
SECONDARY OBJECTIVE:
II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic
disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC
results and standard hematoxylin and eosin (H&E) results.
OUTLINE:
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine
green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel
lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full
pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard
hysterectomy and salpingo-oophorectomy.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years for a total of 5 years according to the standard surveillance
guidelines for endometrial cancer.
Study Type
Interventional
Primary Outcome
negative predictive value of sentinel lymph node prediction of metastatic disease
Secondary Outcome
Percentage of metastatic cases found using ultra-sectioning and IHC staining
Condition
Endometrial Cancer
Intervention
sentinel lymph node detection
Study Arms / Comparison Groups
sentinel lymph node detection
Description: Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
204
Start Date
February 2013
Completion Date
March 31, 2017
Primary Completion Date
November 16, 2016
Eligibility Criteria
Inclusion Criteria:
- The patient must be willing and able to provide informed consent
- The patient is willing and able to comply with the study protocol
- The patient has endometrial cancer and is scheduled for robotic hysterectomy and
lymphadenectomy
- The patient agrees to follow-up examinations out to 5-years post-treatment
Exclusion Criteria:
- The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy
- The patient has known or suspected allergies to iodine, indocyanine green (ICG) or
isosulfan blue (ISB)
- The patient has hepatic dysfunction confirmed by bilirubin > 2 x normal (based on
reference values from the laboratory used by the patient)
Gender
Female
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Floor Backes, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01818739
Organization ID
OSU-12114
Secondary IDs
NCI-2013-00530
Responsible Party
Principal Investigator
Study Sponsor
Ohio State University Comprehensive Cancer Center
Study Sponsor
Floor Backes, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center
Verification Date
September 2017