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

Overview

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.

Full Title of Study: “Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

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.

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

Arms, Groups and Cohorts

  • Experimental: Diagnostic
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity
    • Time Frame: At the time of surgery
    • Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
  • False Negative Predictive Value (FNPV)
    • Time Frame: At the time of Surgery
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gynecologic Oncology Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Charles Levenback, Principal Investigator, Gynecologic Oncology Group

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