NCT01818739

Lymph Node Mapping in Patients With Endometrial Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	sentinel lymph node detection	Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
DRUG	indocyanine green solution	Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
DRUG	isosulfan blue	Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
PROCEDURE	sentinel lymph node biopsy	Undergo sentinel lymph node biopsy

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-11-16
• Completion: 2017-03-31
• First posted: 2013-03-26
• Last updated: 2023-03-22
• Results posted: 2021-06-22

Locations

2 sites across 1 country: United States