Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Lymph Node Mapping in Diagnosing Patients With Endometrial Cancer

Protocol: OSU-12114

Full 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

Purpose

This clinical trial studies lymph node mapping in diagnosing patients with endometrial cancer. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.

Study Objective

PRIMARY OBJECTIVES:

I. To estimate the standard validation parameters (sensitivity, specificity, negative and positive predictive value) of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis.

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.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Are you eligible?

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)

Endometrial Cancer Gynecologic Cancers