Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer - Full Text View

Purpose

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	Intervention
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


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Biopsy Cancer Cervical Cancer Nuclear Scans

Drug Information available for: Methylene Blue Sulfur, precipitated Isosulfan blue

U.S. FDA Resources

Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:

Sensitivity, defined as the proportion of patients who test as SN (+) among the patients who have LN metastases (LN+) [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
The confidence interval of the sensitivity will be calculated by appropriate method.

Secondary Outcome Measures:

Success rate of SN identification [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]


Enrollment:	102
Study Start Date:	June 2004
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070317

Locations


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

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Charles Levenback	Gynecologic Oncology Group

More Information


Responsible Party:	Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00070317 History of Changes
Other Study ID Numbers:	GOG-0206 NCI-2012-02559 CDR0000331918 GOG-0206 GOG-0206 U10CA027469
Study First Received:	October 3, 2003
Last Updated:	June 3, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Carcinoma Carcinoma, Squamous Cell Adenocarcinoma Uterine Cervical Neoplasms Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female	Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Methylene Blue Technetium Tc 99m Sulfur Colloid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Radiopharmaceuticals

ClinicalTrials.gov processed this record on September 30, 2016