Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00450723|
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : April 5, 2013
Last Update Posted : February 7, 2017
RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Isosulfan blue Procedure: Axillary Lymph Node Dissection Procedure: Surgery Procedure: Sentinel Lymph Node Biopsy Procedure: Thoracoscopic Surgery Radiation: Technetium Tc 99m Sulfur Colloid|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thoracoscopic Internal Mammary Sentinel Node Biopsy|
|Study Start Date :||May 2004|
|Primary Completion Date :||January 2011|
|Study Completion Date :||March 2011|
U.S. FDA Resources
|Experimental: Sentinel Lymph Node Biopsy||
Drug: 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.
Other Name: LymphazurinProcedure: Axillary Lymph Node Dissection
Axillary Lymph Node DissectionProcedure: 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.Procedure: Sentinel Lymph Node Biopsy
Sentinel Lymph Node BiopsyProcedure: Thoracoscopic Surgery
Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.Radiation: 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
- Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy [ Time Frame: 5 years ]
- Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes [ Time Frame: 5 years ]
- Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes [ Time Frame: 5 years ]
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): NCT00450723
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Eli Avisar, MD||University of Miami Sylvester Comprehensive Cancer Center|