Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
NCT ID: NCT00070317
Last Updated: 2017-11-06
Study Results
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View full resultsBasic Information
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TERMINATED
NA
102 participants
INTERVENTIONAL
2004-06-30
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Isosulfan Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Lymph Node Mapping
Undergo lymphatic mapping
Lymphangiography
Undergo lymphangiography using isosulfan blue or methylene blue
Methylene Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Radionuclide Imaging
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Sentinel Lymph Node Biopsy
Undergo complete pelvic and low para-aortic lymphadenectomy
Technetium Tc-99m Sulfur Colloid
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Therapeutic Conventional Surgery
Undergo radical hysterectomy
Interventions
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Isosulfan Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Lymph Node Mapping
Undergo lymphatic mapping
Lymphangiography
Undergo lymphangiography using isosulfan blue or methylene blue
Methylene Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Radionuclide Imaging
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Sentinel Lymph Node Biopsy
Undergo complete pelvic and low para-aortic lymphadenectomy
Technetium Tc-99m Sulfur Colloid
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Therapeutic Conventional Surgery
Undergo radical hysterectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Charles Levenback
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2012-02559
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000331918
Identifier Type: -
Identifier Source: secondary_id
GOG-0206
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0206
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0206
Identifier Type: -
Identifier Source: org_study_id