Conditions: Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Stage I Cervical Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 102
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: Isosulfan Blue intervention 2: Lymph Node Mapping intervention 3: Lymphangiography intervention 4: Methylene Blue intervention 5: Radionuclide Imaging intervention 6: Sentinel Lymph Node Biopsy intervention 7: Technetium Tc-99m Sulfur Colloid intervention 8: Therapeutic Conventional Surgery
Intervention descriptions: intervention 1: Undergo lymphangiography using isosulfan blue or methylene blue intervention 2: Undergo lymphatic mapping intervention 3: Undergo lymphangiography using isosulfan blue or methylene blue intervention 4: Undergo lymphangiography using isosulfan blue or methylene blue intervention 5: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid intervention 6: Undergo complete pelvic and low para-aortic lymphadenectomy intervention 7: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid intervention 8: Undergo radical hysterectomy

Protocol document: