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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00070317
Recruitment Status : Terminated
First Posted : October 7, 2003
Results First Posted : October 3, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Stage I Cervical Cancer Drug: Isosulfan Blue Procedure: Lymph Node Mapping Procedure: Lymphangiography Drug: Methylene Blue Procedure: Radionuclide Imaging Procedure: Sentinel Lymph Node Biopsy Radiation: Technetium Tc-99m Sulfur Colloid Procedure: Therapeutic Conventional Surgery Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
Study Start Date : June 2004
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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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 Name: lymphatic mapping

Procedure: Lymphangiography
Undergo lymphangiography using isosulfan blue or methylene blue
Other Name: Lymphography

Drug: Methylene Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
  • 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
  • Urolene Blue
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070317


Locations
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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Charles Levenback Gynecologic Oncology Group
More Information
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00070317    
Other Study ID Numbers: GOG-0206
NCI-2012-02559 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000331918
GOG-0206 ( Other Identifier: Gynecologic Oncology Group )
GOG-0206 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2003    Key Record Dates
Results First Posted: October 3, 2017
Last Update Posted: November 6, 2017
Last Verified: June 2015
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Neoplasms, Complex and Mixed
Methylene Blue
Technetium Tc 99m Sulfur Colloid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals