Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isosulfan blue
Axillary Lymph Node Dissection
Surgery
Sentinel Lymph Node Biopsy
Thoracoscopic Surgery
Technetium Tc 99m Sulfur Colloid
Sponsored by

About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, male breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
Sites / Locations
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sentinel Lymph Node Biopsy
Arm Description
Outcomes
Primary Outcome Measures
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00450723
Brief Title
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
Official Title
Thoracoscopic Internal Mammary Sentinel Node Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage I breast cancer, stage II breast cancer, male breast cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sentinel Lymph Node Biopsy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Isosulfan blue
Other Intervention Name(s)
Lymphazurin
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Axillary Lymph Node Dissection
Intervention Description
Axillary Lymph Node Dissection
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sentinel Lymph Node Biopsy
Intervention Description
Sentinel Lymph Node Biopsy
Intervention Type
Procedure
Intervention Name(s)
Thoracoscopic Surgery
Intervention Description
Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
Intervention Type
Radiation
Intervention Name(s)
Technetium Tc 99m Sulfur Colloid
Intervention Description
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
Primary Outcome Measure Information:
Title
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
Time Frame
5 years
Title
Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
Time Frame
5 years
Title
Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Avisar, MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18723148
Citation
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.
Results Reference
result
Learn more about this trial
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
We'll reach out to this number within 24 hrs