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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Stage I Cervical Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic<br>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<br>* Undergo lymphangiography using isosulfan blue or methylene blue<br>* Other names: N-[4-[(4-(diethylamino)phenyl)(2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-ethanaminium hydroxide;Procedure: Lymph Node Mapping<br>* Undergo lymphatic mapping<br>* Other names: lymphatic mapping;Procedure: Lymphangiography<br>* Undergo lymphangiography using isosulfan blue or methylene blue<br>* Other names: Lymphography;Drug: Methylene Blue<br>* Undergo lymphangiography using isosulfan blue or methylene blue<br>* Other names: Vitableu;Procedure: Radionuclide Imaging<br>* Undergo radionuclide imaging with technetium Tc 99m sulfur colloid<br>* Other names: SCINTIGRAPHY;Procedure: Sentinel Lymph Node Biopsy<br>* Undergo complete pelvic and low para-aortic lymphadenectomy<br>* Other names: SNB;Radiation: Technetium Tc-99m Sulfur Colloid<br>* Undergo radionuclide imaging with technetium Tc 99m sulfur colloid<br>* Other names: Technetium Tc 99m Sulfur Colloid;Procedure: Therapeutic Conventional Surgery<br>* Undergo radical hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | 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) | 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 |