NCT01939028

Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

Sentinel Lymph Node Mapping for Endometrial Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.

Detailed description

PRIMARY OBJECTIVES: I. To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients. SECONDARY OBJECTIVES: I. To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy. II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures. OUTLINE: Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. After completion of study treatment, patients are followed up at 2-4 weeks.

Conditions

• Stage I Endometrial Carcinoma
• Stage II Endometrial Carcinoma
• Stage III Endometrial Carcinoma
• Stage IV Endometrial Carcinoma

Interventions

Type	Name	Description
PROCEDURE	lymph node mapping	Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
PROCEDURE	sentinel lymph node biopsy	Undergo SLN biopsy
DRUG	isosulfan blue	Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
DRUG	indocyanine green solution	Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
PROCEDURE	therapeutic conventional surgery	Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy
PROCEDURE	lymphadenectomy	Undergo para-aortic lymphadenectomy

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-09-11
• Last updated: 2020-08-27
• Results posted: 2020-08-17

Locations

1 site across 1 country: United States