Lymph Node Mapping in Patients With Endometrial Cancer

Not Applicable

Completed

• Conditions: Endometrial Cancer
• Interventions: Procedure: sentinel lymph node detection; Drug: indocyanine green solution; Drug: isosulfan blue; Procedure: sentinel lymph node biopsy

• Registration Number: NCT01818739
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Primary Completion: 2016-11-16
• Study Completion: 2017-03-31
• Results First Submitted: 2021-05-11
• Results First Submitted QC: 2021-06-21
• Results First Posted: 2021-06-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 204

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sentinel lymph node detection	sentinel lymph node detection	Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
sentinel lymph node detection	sentinel lymph node biopsy	Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
sentinel lymph node detection	indocyanine green solution	Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
sentinel lymph node detection	isosulfan blue	Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.

Primary Outcome Measures

Name	Time	Method
Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease	average of 1-14 days after the procedure when final pathologic evaluation has been completed	NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated.

Secondary Outcome Measures

Name	Time	Method
Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining	average of 1-14 days after the procedure when final pathologic evalulation has been completed	The percentage of metastatic cases analyzed by H\&E will be compared to those of H\&E-plus- IHC/ultrastaging using a "z-test".

Trial Locations

Locations (2)

Smilow Cancer Hospital at Yale New Haven; 🇺🇸 New Haven, Connecticut, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States