Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
NCT ID: NCT00450723
Last Updated: 2017-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2004-05-31
2011-03-31
Brief Summary
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PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.
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Detailed Description
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* Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
* Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
* Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.
OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.
All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Sentinel Lymph Node Biopsy
Isosulfan blue
Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.
Axillary Lymph Node Dissection
Axillary Lymph Node Dissection
Surgery
The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.
Sentinel Lymph Node Biopsy
Sentinel Lymph Node Biopsy
Thoracoscopic Surgery
Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
Technetium Tc 99m Sulfur Colloid
Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots
Interventions
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Isosulfan blue
Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.
Axillary Lymph Node Dissection
Axillary Lymph Node Dissection
Surgery
The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.
Sentinel Lymph Node Biopsy
Sentinel Lymph Node Biopsy
Thoracoscopic Surgery
Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
Technetium Tc 99m Sulfur Colloid
Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed breast cancer
* Stage I or II disease (T1-T2, N0, M0/MX disease)
* No chest wall invasion by tumor (T3 disease)
* Medially or centrally located lesion
* No multicentric disease
* Multifocal disease allowed
* No clinically positive axillary nodes
* No enlarged internal mammary nodes by CT scan
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* American Society of Anesthesiologists (ASA) physical status classification 1-2
* Not pregnant or nursing
* Negative pregnancy test
* No other concurrent known, invasive malignancy
* No known chronic pulmonary disease
* No known allergy to methylene blue or isosulfan blue
PRIOR CONCURRENT THERAPY:
* No prior thoracic or cardiac surgery
* No prior ipsilateral chest tube placement
* Contralateral chest tube placement allowed
* No prior neoadjuvant chemotherapy
* No prior radiotherapy to the mediastinum
18 Years
120 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Principal Investigators
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Eli Avisar, MD
Role: STUDY_CHAIR
University of Miami Sylvester Comprehensive Cancer Center
Locations
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University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Countries
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References
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Avisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23.
Other Identifiers
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SCCC-2003161
Identifier Type: OTHER
Identifier Source: secondary_id
WIRB-20050911
Identifier Type: OTHER
Identifier Source: secondary_id
20040015
Identifier Type: -
Identifier Source: org_study_id
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