Conditions: Endometrial Cancer
Keywords: Endometrial Cancer Robotic-Assisted Staging
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 204
Healthy volunteers: no

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.

Arms:
arm 1: Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.

Interventions: intervention 1: sentinel lymph node detection intervention 2: indocyanine green solution intervention 3: isosulfan blue intervention 4: sentinel lymph node biopsy
Intervention descriptions: intervention 1: Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue intervention 2: Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue intervention 3: Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue intervention 4: Undergo sentinel lymph node biopsy

Protocol document: