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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Gynecologic Oncology Group

  lead NETWORK

Principal Investigators

• Charles Levenback · Gynecologic Oncology Group

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-06-30

Primary Completion

2013-01-31

Completion

2013-01-31

Countries

• United States

Study Locations