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

Stopped early · Not applicable

Conditions studied: Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma

In brief

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.

Key facts

Study ID

NCT01939028

Run by

Case Comprehensive Cancer Center

People needed

58

Starts

2013-07-01

Expected to finish

2016-10-01

Last updated by the study team

2020-08-27

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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