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Lymph Node Mapping in Patients With Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01818739
Recruitment Status : Completed
First Posted : March 26, 2013
Results First Posted : June 22, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Floor Backes, 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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: sentinel lymph node detection Drug: indocyanine green solution Drug: isosulfan blue Procedure: sentinel lymph node biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 2013
Actual Primary Completion Date : November 16, 2016
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


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 Name: sentinel node biopsy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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".



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818739


Locations
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United States, Connecticut
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06520
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Floor Backes, MD Ohio State University Comprehensive Cancer Center
Additional Information:
Publications:
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Responsible Party: Floor Backes, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01818739    
Other Study ID Numbers: OSU-12114
NCI-2013-00530 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 26, 2013    Key Record Dates
Results First Posted: June 22, 2021
Last Update Posted: June 22, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Floor Backes, Ohio State University Comprehensive Cancer Center:
Endometrial Cancer
Robotic-Assisted Staging
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Pharmaceutical Solutions