Lymph Node Mapping in Patients With Endometrial Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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

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Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

sentinel lymph node detection

Intervention Type PROCEDURE

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

indocyanine green solution

Intervention Type DRUG

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

isosulfan blue

Intervention Type DRUG

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

sentinel lymph node biopsy

Intervention Type PROCEDURE

Undergo sentinel lymph node biopsy

Interventions

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sentinel lymph node detection

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

Intervention Type PROCEDURE

indocyanine green solution

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

Intervention Type DRUG

isosulfan blue

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

Intervention Type DRUG

sentinel lymph node biopsy

Undergo sentinel lymph node biopsy

Intervention Type PROCEDURE

Other Intervention Names

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IC-GREEN ICG solution Lymphazurin N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide sentinel node biopsy

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No