Lymph Node Mapping in Patients With Endometrial Cancer

The Ohio State University

Status: Completed

Conditions: Endometrial Cancer

Treatments: Procedure: sentinel lymph node detection; Drug: indocyanine green solution; Procedure: sentinel lymph node biopsy; Drug: isosulfan blue

Study type: Interventional

Funder types: Other

Identifiers

NCT01818739

OSU-12114

NCI-2013-00530 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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204 participants in 1 patient group

sentinel lymph node detection

Experimental group

Description:

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

Treatment:

Drug: isosulfan blue

Procedure: sentinel lymph node biopsy

Drug: indocyanine green solution

Procedure: sentinel lymph node detection