NCT00070317

Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Squamous Cell Carcinoma
• Stage I Cervical Cancer

Interventions

Type	Name	Description
DRUG	Isosulfan Blue	Undergo lymphangiography using isosulfan blue or methylene blue
PROCEDURE	Lymph Node Mapping	Undergo lymphatic mapping
PROCEDURE	Lymphangiography	Undergo lymphangiography using isosulfan blue or methylene blue
DRUG	Methylene Blue	Undergo lymphangiography using isosulfan blue or methylene blue
PROCEDURE	Radionuclide Imaging	Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
PROCEDURE	Sentinel Lymph Node Biopsy	Undergo complete pelvic and low para-aortic lymphadenectomy
RADIATION	Technetium Tc-99m Sulfur Colloid	Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
PROCEDURE	Therapeutic Conventional Surgery	Undergo radical hysterectomy

Timeline

• Start date: 2004-06-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2003-10-07
• Last updated: 2017-11-06
• Results posted: 2017-10-03

Locations

1 site across 1 country: United States