Status:
COMPLETED
Lymph Node Mapping in Patients With Endometrial Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-85 years
Phase:
NA
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 treatme...
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 abilit...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2017
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01818739
Start Date
March 1 2013
End Date
March 31 2017
Last Update
March 22 2023
Active Locations (2)
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1
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06520
2
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210