Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
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.
Inclusion Criteria:

 -  Diagnosis of carcinoma of the cervix of 1 of the following cellular types:

 -  Squamous cell carcinoma

 -  Adenocarcinoma

 -  Adenosquamous cell carcinoma

 -  Stage IB1 disease (no greater than 4 cm)

 -  No unequivocal evidence of metastases

 -  Adequate surgical candidate

 -  No known allergy to triphenylmethane compounds

 -  No prior pelvic irradiation

 -  No prior retroperitoneal surgery

 -  More than 4 weeks since prior cold knife or loop electrosurgical excision procedure
 (LEEP) cone biopsy

 -  Prior cone biopsy allowed provided current disease is stage IB1