Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
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ClinicalTrials.gov Identifier: NCT00070317 |
Recruitment Status :
Terminated
First Posted : October 7, 2003
Results First Posted : October 3, 2017
Last Update Posted : November 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 (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 |

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.
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Drug: Isosulfan Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
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:
Procedure: Radionuclide Imaging Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Other Names:
Procedure: Sentinel Lymph Node Biopsy Undergo complete pelvic and low para-aortic lymphadenectomy
Other Names:
Radiation: Technetium Tc-99m Sulfur Colloid Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Other Names:
Procedure: Therapeutic Conventional Surgery Undergo radical hysterectomy |
- 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.
- 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

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

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
United States, Pennsylvania | |
Gynecologic Oncology Group | |
Philadelphia, Pennsylvania, United States, 19103 |
Principal Investigator: | Charles Levenback | Gynecologic Oncology Group |
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 |
Carcinoma 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 |