Lymph Node Mapping in Patients With Endometrial Cancer

March 21, 2023 updated by: Floor Backes, Ohio State University Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Smilow Cancer Hospital at Yale New Haven
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Other Names:
  • IC-GREEN
  • ICG solution
Drug: isosulfan blue
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
Other Names:
  • Lymphazurin
  • N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Procedure: sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
Other Names:
  • sentinel node biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease
Time Frame: 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.
average of 1-14 days after the procedure when final pathologic evaluation has been completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining
Time Frame: 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".
average of 1-14 days after the procedure when final pathologic evalulation has been completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Floor Backes, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

November 16, 2016

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-12114
  • NCI-2013-00530 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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