- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00070317
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
Undergo lymphatic mapping
Other Names:
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Other Names:
Undergo complete pelvic and low para-aortic lymphadenectomy
Other Names:
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Other Names:
Undergo radical hysterectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity
Time Frame: At the time of surgery
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Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
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At the time of surgery
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False Negative Predictive Value (FNPV)
Time Frame: At the time of Surgery
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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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At the time of Surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Levenback, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Neoplasms, Complex and Mixed
- Uterine Cervical Neoplasms
- Carcinoma
- Carcinoma, Adenosquamous
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Radiopharmaceuticals
- Methylene Blue
- Technetium Tc 99m Sulfur Colloid
Other Study ID Numbers
- GOG-0206 (Other Identifier: CTEP)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2012-02559 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000331918
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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