This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
OBJECTIVES: I. Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using preoperative or intraoperative lymphatic mapping, in patients with stage IB1 cervical cancer. II. Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients. OUTLINE: This is a multicenter study. Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
102
Undergo lymphangiography using isosulfan blue or methylene blue
Undergo lymphatic mapping
Undergo lymphangiography using isosulfan blue or methylene blue
Undergo lymphangiography using isosulfan blue or methylene blue
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Undergo complete pelvic and low para-aortic lymphadenectomy
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Undergo radical hysterectomy
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Sensitivity
Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
Time frame: At the time of surgery
False Negative Predictive Value (FNPV)
The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases
Time frame: At the time of Surgery
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