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

October 3, 2017 updated by: Gynecologic Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Gynecologic Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Isosulfan Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
  • Lymphazurin
  • N-[4-[(4-(diethylamino)phenyl)(2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-ethanaminium hydroxide
Procedure: Lymph Node Mapping
Undergo lymphatic mapping
Other Names:
  • lymphatic mapping
Procedure: Lymphangiography
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
  • Lymphography
Drug: Methylene Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
  • Urolene Blue
  • Azul de Metileno
  • Azul Metile
  • Blu di Metilene
  • CI Basic Blue 9
  • CI-52015
  • Collubleu
  • Colour Index No. 52015
  • Desmoidpillen
  • Methylenum Caeruleum
  • Methylthioninii Chloridum
  • Methylthioninium Chloride
  • Schultz No. 1038
  • Tetramethylthionine Chloride Trihydrate
  • Vitableu
Procedure: Radionuclide Imaging
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Other Names:
  • nuclear medicine scan
  • radioimaging
  • Radionuclide Scanning
  • Scan
  • SCINTIGRAPHY
Procedure: Sentinel Lymph Node Biopsy
Undergo complete pelvic and low para-aortic lymphadenectomy
Other Names:
  • Sentinel Node Biopsy
  • Sentinel node biopsy alone
  • SLNB
  • SNB
Radiation: Technetium Tc-99m Sulfur Colloid
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Other Names:
  • Tc 99m Sulfur Colloid
  • Tc-99m SC
  • Technetium Tc 99m Sulfur Colloid
Procedure: Therapeutic Conventional Surgery
Undergo radical hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the time of surgery
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
At the time of Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Charles Levenback, Gynecologic Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 3, 2003

First Submitted That Met QC Criteria

October 6, 2003

First Posted (Estimate)

October 7, 2003

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0206 (Other Identifier: CTEP)
  • U10CA027469 (U.S. NIH Grant/Contract)
  • NCI-2012-02559 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000331918

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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