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

• Status: Terminated
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer

• Women should have received no prior therapy for their disease

• Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer

• Women must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Women who are receiving any other investigational agents

• Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study

• Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides

• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix

• Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)

• Women with a history of a prior malignancy

• Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate